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DxTerity™ Angio-Kit AKSTAN601

by Medtronic, Inc.

Ref AKSTAN601

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

CE MDR

Valid until

19 Jul 2031

CE MDR certificate

FDA recalls

None ongoing

2 closed

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 730924 Date4 Jun 2026IssuedStatusActive expires 19 Jul 2031
United StatesGUDID listing GUDID Number00763000394585 UDI-DI Date27 Oct 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 730924 Active Reissued

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    4 Jun 2026
    Expires
    19 Jul 2031
    Valid from
    20 Jul 2026

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

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  • Withdrawn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
DxTerity™ EUDAMED
DxTerity™ Angio-Kit GUDID
Generic Name
Angiographic catheter, single-use
Device Name
DxTerity Diagnostic Catheter
Model / Reference
AKSTAN601
Primary DI / UDI-DI
00763000394585
Basic UDI-DI
0763000B00001056V
510(k) Number
FDA Product Code
DQO
EMDN Code
C0104010101 Cardiac angiography diagnostic catheters
GMDN Term
Angiographic catheter, single-use
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1200
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 6.0 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K161287)

Show all (12)

Other devices from Medtronic, Inc.

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Properties

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

Other properties (20)

  • 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
  • Expiration Date: No
  • Manufacturing Date: No