Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter C2IVL3012

GUDID 00195451000096

The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.

Shockwave Medical, Inc.

Ultrasonic lithotripsy system transducer, single-use
Primary Device ID00195451000096
NIH Device Record Key1981958b-507c-437c-bc01-52848cb5ccb0
Commercial Distribution StatusIn Commercial Distribution
Brand NameShockwave IVL System with the Shockwave C2 Coronary IVL Catheter
Version Model Number3.0 x 12mm
Catalog NumberC2IVL3012
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

Device Dimensions

Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere
Balloon Diameter3 Millimeter
Balloon Length12 Millimeter
Catheter Working Length138 Centimeter
Introducer Sheath Compatibilit6 French
Balloon Proximal Outer Diamete0.045 Inch
Guidewire Diameter0.014 Inch
Balloon Nominal (Inflation) Pr6 Atmosphere
Balloon Rated Burst Pressure10 Atmosphere

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100195451000096 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QMGShockwave Intravascular Lithotripsy System

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-25
Device Publish Date2021-02-17

On-Brand Devices [Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter]

00195451000119The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary art
00195451000102The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary art
00195451000096The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary art
00195451000089The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary art
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