Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL3560

GUDID 00195451000201

The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized lithotripsy emitters, located inside a balloon, that generate acoustic pressure waves within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. Two radiopaque marker bands inside the balloon aid in positioning. The proximal hub has three ports: one for inflation/deflation of the balloon with 50/50 saline/contrast medium, one for the ‘Over-the-wire’ (OTW) guidewire lumen, and one for connection to the IVL Connector Cable (and IVL Generator).

Shockwave Medical, Inc.

Ultrasound thrombolysis system catheter, peripheral

• Primary Device ID: 00195451000201
• NIH Device Record Key: 978b0e25-1c21-411c-bb60-f516a22dcb0f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
• Version Model Number: 3.5x60mm
• Catalog Number: M5PIVL3560
• Company DUNS: 055514478
• Company Name: Shockwave Medical, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com
• Phone: 1-877-775-4846
• Email: cs@shockwavemedical.com

Device Dimensions

• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch
• Catheter Working Length: 135 Centimeter
• Balloon Diameter: 3.5 Millimeter
• Balloon Nominal (Inflation) Pr: 6 Atmosphere
• Balloon Rated Burst Pressure: 10 Atmosphere
• Balloon Length: 60 Millimeter
• Introducer Sheath Compatibilit: 6 French
• Balloon Proximal Outer Diamete: 0.078 Inch
• Guidewire Diameter: 0.014 Inch

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
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• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry and keep away from heat

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000201 [Primary]

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-05-19
• Device Publish Date: 2021-05-11

On-Brand Devices [Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+]

• 00195451000287: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000270: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000263: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000256: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000249: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000232: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000225: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000218: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized
• 00195451000201: The Shockwave M5+ Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized