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AXS Catalyst 5 M003IC0581320

by Stryker Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

3 closed

Documents

None

No authorization documents

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613327011999 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0276-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0275-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0277-2018 FDA Class II initiated 3 Nov 2017

    Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
AXS Catalyst 5
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
M003IC0581320, IC058132
Primary DI / UDI-DI
07613327011999
FDA Product Code
DQY, NRY
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1250
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Lumen/Inner Diameter — 0.058 Inch
Length — 132.0 Centimeter

Related devices

Category: Vascular guide-catheter, single-use

Cleared under the same submission (K151667)

Cleared under the same submission (K173841)

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

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

Other properties (9)

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