Skip to content

DIAMONDBACK 360™ Coronary Orbital Atherectomy System

by Cardiovascular Systems, Inc.

Ref C-2DB-CL125-135

Active European Union

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-10850000491417 Basic UDI-DI 10850000491417UDI-DIDate16 Oct 2026RegisteredStatusActive

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  • Withdrawn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/MDD Active

Specification

EUDAMED

Device Name
Coronary Orbital Atherectomy System
Model / Reference
C-2DB-CL125-135
Primary DI / UDI-DI
10850000491417
Basic UDI-DI
B-10850000491417
EMDN Code
C010401020402 Coronary artery atherectomy systems, rotational
Device Class
Class III
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000047663
Authorised representative
ICON (LR) Limited IE-AR-000006507

Other devices from Cardiovascular Systems, Inc.

See all devices from Cardiovascular Systems, Inc. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No