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Artix Thin-Walled Sheath, 90 cm

by Inari Medical, Inc.

Ref 30-104Model 30-103

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

CE MDR

Valid until

8 Nov 2028

CE MDR certificate

FDA recalls

1 ongoing

Recall on shared 510(k) K241894; other models may be affected

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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 Number1000332280 Date25 Sep 2026IssuedStatusActive expires 8 Nov 2028
United StatesGUDID listing GUDID Number00810123710577 UDI-DI Date11 Nov 2024ListedStatusListed GUDID: in commercial distribution

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

1 recall · 1 ongoing · FDA

    • Ongoing Z-1728-2025 FDA Class II initiated 8 Apr 2025 on shared 510(k) K241894

    Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, which has the potential of vascular complications.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
Artix Thin-Walled Sheath, 90 cm EUDAMED
Artix Thin-Walled Sheath GUDID
Generic Name
Thrombectomy wire-net
Device Name
Artix Thin-Walled Sheath, 65 cm
Model / Reference
30-103, 30-104
Primary DI / UDI-DI
00810123710577
Basic UDI-DI
081012371ARTIXSH7W
Direct Marketing DI
00810123710577
FDA Product Code
KRA, DQY, DYB
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Thrombectomy wire-net
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1210, 870.1250, 870.1340
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Inari Medical, Inc.

See all devices from Inari Medical, Inc. →

Properties

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

Other properties (19)

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