Shockwave M5 M5IVL6060
GUDID 00195451000171
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 | 00195451000171 |
| NIH Device Record Key | cbedc172-d560-4da7-a5c0-daca75587e31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Shockwave M5 |
| Version Model Number | 6.0 x 60mm |
| Catalog Number | M5IVL6060 |
| 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 | false |
| 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 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com | |
| Phone | 1-877-775-4846 |
| cs@shockwavemedical.com |
Device Dimensions
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
| Balloon Diameter | 6 Millimeter |
| Guidewire Diameter | 0.014 Inch |
| Balloon Nominal (Inflation) Pr | 6 Atmosphere |
| Balloon Rated Burst Pressure | 10 Atmosphere |
| Balloon Length | 60 Millimeter |
| Balloon Proximal Outer Diamete | 0.064 Inch |
| Catheter Working Length | 110 Centimeter |
| Introducer Sheath Compatibilit | 6 French |
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 |
| 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 | 00195451000171 [Primary] |
| HIBCC | M732M5IVL60600 [Previous] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K180958
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 | 2021-02-12 |
| Device Publish Date | 2021-02-04 |
On-Brand Devices [Shockwave M5]
| M732M5IVL70600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL65600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL60600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL55600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL50600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL45600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL40600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| M732M5IVL35600 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000195 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000188 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000171 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000164 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000157 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000140 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000133 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
| 00195451000126 | The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l |
Trademark Results [Shockwave M5]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SHOCKWAVE M5 87787686 5814410 Live/Registered |
Shockwave Medical, Inc. 2018-02-07 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.