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Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter

FDA UDI

Class III (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter FDA UDI
Generic Name
Intravascular lithotripsy system balloon catheter, coronary FDA UDI
Device Name
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. FDA UDI
Model / Reference
C2IVL3012 FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
C2IVL3012 FDA UDI
Primary DI / UDI-DI
00195451000096 FDA UDI
PMA Number
P200039 FDA UDI
FDA Product Code
QMG FDA UDI
GMDN Term
Intravascular lithotripsy system balloon catheter, coronary FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Balloon Diameter — 3.0 Millimeter FDA UDI
Balloon Length — 12 Millimeter FDA UDI
Catheter Working Length — 138 Centimeter FDA UDI
Introducer Sheath Compatibility — 6 French FDA UDI
Balloon Proximal Outer Diameter (OD) — 0.045 Inch FDA UDI
Guidewire Diameter — 0.014 Inch FDA UDI
Balloon Nominal (Inflation) Pressure — 6 Atmosphere FDA UDI
Balloon Rated Burst Pressure — 10 Atmosphere FDA UDI

Category: Intravascular lithotripsy system balloon catheter, coronary

Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter by Shockwave Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Intravascular lithotripsy system balloon catheter, coronary.

Cleared under the same submission

P200039 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shockwave Medical, Inc.

Sources (1)

  • FDA UDI 1981958b-507c-437c-bc01-52848cb5ccb0 38 fields · synced May 30, 2026