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Axs Infinity Ls Plus Inc-11196-80

by Stryker Corp.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

1 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 Number07613327459197 UDI-DI Date8 Oct 2018ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · FDA

    • Terminated Z-1708-2019 FDA Class II initiated 18 Apr 2019

    A design related issue can contribute to the device exhibiting brittle behavior. This behavior may result in fractures of the catheter shaft.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Axs Infinity Ls Plus
Generic Name
Vascular guide-catheter, single-use
Model / Ref / Catalog
INC-11196-80
Primary DI / UDI-DI
07613327459197
510(k) Number
FDA Product Code
DQY, DTL, GCC
GMDN Term
Vascular guide-catheter, single-use
Device Class
Class II
Regulation Number
870.1250, 870.4290, 878.4200
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 0.091 Inch
Length — 80.0 Centimeter

Related devices

Category: Vascular guide-catheter, single-use

Cleared under the same submission (K172468)

Cleared under the same submission (K193034)

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