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ClotTriever Sheath

by Inari Medical, Inc.

Ref 50-101Model 51-101

Active European Union and United States

CE MDR 510(k)

Valid until

8 Nov 2028

CE MDR certificate

FDA recalls

None found

in data synced 24 Oct 2026

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

510(k) K233815↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number1000332280 Date25 Sep 2026IssuedStatusActive expires 8 Nov 2028
United StatesFDA 510(k) 510(k) NumberK233815 Date18 Dec 2023IssuedStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000332280 Restricted

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    25 Sep 2026
    Expires
    8 Nov 2028
    Reason
    Other

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  • Withdrawn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 FDA 510(k) Active

Specification

EUDAMED · 510(k)

Device Name
ClotTriever Sheath 16Fr
Model / Reference
51-101, 50-101
Primary DI / UDI-DI
00850291007604
Basic UDI-DI
0850291007CT9Y
Direct Marketing DI
00850291007604
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008693
Authorised representative
Emergo Europe B.V. NL-AR-000000116

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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