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Artix MT, MT6

by Inari Medical, Inc. United States EUDAMEDGUDID

Ref 32-102Model 31-101

Product code KRAEMDN C010402020702

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081012371ARTIXCT76 Basic UDI-DIDate30 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810123710584 UDI-DIDate11 Nov 2024ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates: none listed in EUDAMED

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1728-2025 FDA Class II initiated 8 Apr 2025 via K241894, on the same 510(k)

    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 marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Artix MT, MT6 EUDAMED
Artix MT GUDID
Generic Name
Thrombectomy wire-net
Device Name
Artix AX, 85 cm
Model / Reference
31-101 EUDAMED
32-102 EUDAMED
32-102 / AS-01248 GUDID
Primary DI / UDI-DI
00810123710584
Basic UDI-DI
081012371ARTIXCT76
Direct Marketing DI
00810123710584
510(k) Number
FDA Product Code
KRA, DQY, DYB
EMDN Code
C010402020702 Mechanical peripheral thrombectomy and thromboaspiration systems
GMDN Term
Thrombectomy wire-net
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1210, 870.1250, 870.1340
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
31-101
32-102
GUDID
32-102 / AS-01248
Device ClassEUDAMED
Class IIa
GUDID
Class II
Contains LatexEUDAMED
No
GUDID
Yes

Manufacturer details

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

Other devices from Inari Medical, Inc.

See all devices from Inari Medical, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Implantable: No
  • Reusable: 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

Sources (2)

  • EUDAMED 685863c3-6292-445f-a037-179f7b97a55d 61 fields · synced 23 Oct 2026
  • FDA UDI df4a6800-8592-4d44-8410-272d139bd7b4 35 fields · synced 30 May 2026