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Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter + Cable Sleeve

by Shockwave Medical Inc. 2 variants

Ref C2KIVL4012

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number00195451C2KIVLXX Basic UDI-DI 00195451000454UDI-DIDate14 Jul 2022RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
C2KIVL4012
Primary DI / UDI-DI
00195451000454
Basic UDI-DI
00195451C2KIVLXX
EMDN Code
C01040199 Cardiac angiography devices - other
Device Class
Class III
Medical Purpose
The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2+ Coronary IVL Catheter is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of calcified, stenotic de novo coronary arteries prior to stenting.

Manufacturer details

EUDAMED SRN
US-PR-000012771

From the manufacturer

Manufacturer's product page: IVL for Coronary Artery Disease

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Properties

  • Sterile