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Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter

FDA UDI

Class III (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name
Shockwave IVL System w/ Shockwave C2 Aero Coronary IVL Catheter FDA UDI
Generic Name
Intravascular lithotripsy system balloon catheter, coronary FDA UDI
Device Name
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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
C2AIVL3012 FDA UDI
Description
The Shockwave C2 Aero Coronary IVL 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 stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. 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 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, 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
C2AIVL3012 FDA UDI
Primary DI / UDI-DI
00195451000607 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

Yes

FDA UDI

Dimensions & Sizes

Size
Balloon Length — 12 Millimeter FDA UDI
Balloon Diameter — 3.0 Millimeter FDA UDI
Balloon Proximal Outer Diameter (OD) — 0.045 Inch FDA UDI
Catheter Length — 138 Centimeter FDA UDI
Guidewire Compatibility — 6 French FDA UDI

Category: Intravascular lithotripsy system balloon catheter, coronary

Shockwave IVL System w/ Shockwave C2 Aero 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 b6f40468-4c54-498c-9abe-5e22a3c021b4 38 fields · synced Jun 8, 2026