Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter L6IVL120030

GUDID 00195451000416

The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial system of the lower extremities to the site of an otherwise difficult to treat calcified stenosis. Energizing the lithotripsy device will generate pulsatile mechanical energy within the target treatment site, disrupting calcium within the lesion and allowing subsequent dilation of a peripheral artery stenosis using low balloon pressure. The IVL Catheter is comprised of an integrated balloon with an array of lithotripsy emitters for the localized delivery of pulsatile mechanical energy. The system consists of an IVL Catheter, an IVL Connector Cable and an IVL Generator. The IVL Catheter is available in four (4) sizes: 8.0 x 30mm, 9.0 x 30mm, 10.0 x 30mm, and 12.0 x 30mm. The L6 Peripheral IVL Catheter is compatible with a 7 or 8F sheath and has a working length of 110cm. The Shockwave L6 Peripheral IVL Catheter shaft contains an inflation lumen, a guidewire lumen, and the lithotripsy emitters. The inflation lumen is used for inflation and deflation of the balloon with 50/50 saline/contrast medium. The guidewire lumen enables the use of a 0.018” guidewire to facilitate advancement of the catheter to and through the target stenosis. The system is designed as ‘Over-the-wire’ (OTW) with 110cm shaft working length, so an exchange length (300cm) guidewire is indicated. The emitters are positioned along the length of the balloon working length for delivery of pulsatile mechanical energy. The balloon is located near the distal tip of the catheter. Two radiopaque marker bands within the balloon denote the length of the balloon to aid in positioning of the balloon during treatment. The balloon is designed to provide an expandable segment of known length and diameter at a specific pressure. The proximal hub has three ports: one for inflation/deflation of the balloon, one for guidewire lumen, and one for connection to the IVL Connector Cable.

Shockwave Medical, Inc.

Ultrasonic lithotripsy system transducer, single-use

• Primary Device ID: 00195451000416
• NIH Device Record Key: fb136168-c6bc-42e5-a84c-39f493143b5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter
• Version Model Number: 12.0x30mm
• Catalog Number: L6IVL120030
• 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

Device Dimensions

• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere
• Catheter Working Length: 110 Centimeter
• Balloon Proximal Outer Diamete: 0.104 Inch
• Balloon Diameter: 12 Millimeter
• Balloon Length: 30 Millimeter
• Introducer Sheath Compatibilit: 8 French
• Guidewire Diameter: 0.018 Inch
• Balloon Nominal (Inflation) Pr: 2 Atmosphere
• Balloon Nominal (Inflation) Pr: 3 Atmosphere
• Balloon Nominal (Inflation) Pr: 4 Atmosphere
• Balloon Rated Burst Pressure: 6 Atmosphere

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195451000416 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221852

FDA Product Code

• PPN: Percutaneous Catheter, Ultrasound

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: 2022-11-01
• Device Publish Date: 2022-10-24

On-Brand Devices [Shockwave Medical L6 Intravascular Lithotripsy (IVL) Catheter]

• 00195451000416: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000409: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000393: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s
• 00195451000386: The IVL Catheter is a proprietary lithotripsy device delivered through the peripheral arterial s