Shockwave M5 M5IVL4060

GUDID 00195451000133

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.

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Primary Device ID00195451000133
NIH Device Record Key5cb0eea3-5f6e-4e4b-9808-6240fb55cd39
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave M5
Version Model Number4.0 x 60mm
Catalog NumberM5IVL4060
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 Kitfalse
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

Device Dimensions

Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Diameter4 Millimeter
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Length60 Millimeter
Balloon Proximal Outer Diamete0.064 Inch
Catheter Working Length110 Centimeter
Introducer Sheath Compatibilit6 French

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000133 [Primary]
HIBCCM732M5IVL40600 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PPNPercutaneous Catheter, Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-12
Device Publish Date2021-02-04

On-Brand Devices [Shockwave M5]

M732M5IVL70600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL65600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL60600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL55600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL50600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL45600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL40600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
M732M5IVL35600The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000195The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000188The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000171The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000164The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000157The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000140The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000133The Shockwave M5 Intravascular Lithotripsy (IVL) Catheter consists of an array of miniaturized l
00195451000126The 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
SHOCKWAVE M5
87787686 5814410 Live/Registered
Shockwave Medical, Inc.
2018-02-07

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