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Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter C2AFIVL2512

by Shockwave Medical Inc.

Ref C2AFIVL2512

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number00195451C2AFIVLVG Basic UDI-DI 00195451001123UDI-DIDate19 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00195451001123 UDI-DI Date14 May 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Shockwave C2 Aero Fly Coronary Intravascular Lithotripsy (IVL) Catheter + Cable Sleeve EUDAMED
Shockwave IVL System with the Shockwave C2 Aero Fly Coronary IVL Catheter GUDID
Generic Name
Intravascular lithotripsy system catheter, balloon, coronary
Model / Ref / Catalog
C2AFIVL2512
Primary DI / UDI-DI
00195451001123
Basic UDI-DI
00195451C2AFIVLVG
PMA Number
FDA Product Code
QMG
EMDN Code
C01040199 Cardiac angiography devices - other
GMDN Term
Intravascular lithotripsy system catheter, balloon, coronary
Device Class
Class III
Medical Purpose
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 Aero Fly Coronary IVL Catheter is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting.
GUDID distribution status
In Commercial Distribution
Size
Balloon Proximal Outer Diameter (OD) — 0.044 Millimeter
Balloon Diameter — 2.5 Millimeter
Balloon Length — 12 Millimeter
Catheter Length — 138 Centimeter
Guidewire Compatibility — 6 French

From the manufacturer

Manufacturer's product page: Shockwave IVL System

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Cleared under the same submission (P200039)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No