Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ M5PIVL8060

GUDID 00195451000287

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 Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Ultrasound thrombolysis system catheter, peripheral Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Medical equipment drape, single-use Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral Intravascular lithotripsy system balloon catheter, peripheral
Primary Device ID00195451000287
NIH Device Record Keyf067d82b-0216-4b25-8542-b378419435c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+
Version Model Number8.0x60mm
Catalog NumberM5PIVL8060
Company DUNS055514478
Company NameShockwave Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com
Phone1-877-775-4846
Emailcs@shockwavemedical.com

Device Dimensions

Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch
Catheter Working Length135 Centimeter
Balloon Diameter8 Millimeter
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.078 Inch
Guidewire Diameter0.014 Inch

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat
Special Storage Condition, SpecifyBetween 0 and 0 *Keep dry and keep away from heat

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000287 [Primary]

FDA Product Code

OEZCardiovascular Procedure Kit

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-19
Device Publish Date2021-05-11

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.