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DxTerity™ Angio-Kit AKSTAN501

by Medtronic, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

2 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00643169738270 UDI-DI Date30 Sep 2017ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · FDA

    • Terminated Z-3253-2018 FDA Class III initiated 16 Aug 2018

    Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the pouch are the correct U5TRAN35 item, the outer carton has all the correct labeling, and all the other information and configuration details on both the carton and the pouch are correct.

    • Terminated Z-1479-2018 FDA Class II initiated 13 Mar 2018

    The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
DxTerity™ Angio-Kit
Generic Name
Angiographic catheter, single-use
Model / Reference
AKSTAN501
Primary DI / UDI-DI
00643169738270
510(k) Number
FDA Product Code
DQO
GMDN Term
Angiographic catheter, single-use
Device Class
Class II
Regulation Number
870.1200
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 5.0 French

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K161287)

Show all (12)

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

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

Other properties (10)

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