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Infiniti 534649T

by Cordis Corporation

Ref 534-649T

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

7 Jul 2029

CE MDR certificate

FDA recalls

2 ongoing

This device is named in the recall

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K970854

FDA submission, from GUDID

Trust

Unverified

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

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 771918 Date1 Jun 2026IssuedStatusActive expires 7 Jul 2029
United StatesGUDID listing GUDID Number10705032014373 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK970854 Date30 Sep 1997DecidedStatusActive

Official records

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 771918 Active Supplemented

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    1 Jun 2026
    Expires
    7 Jul 2029
    Reason
    Add device or group

Recalls

3 recalls · 2 ongoing · FDA

    • Ongoing Z-0286-2024 FDA Class I initiated 26 Sep 2023

    Non-sterile product labeled as sterile was distributed.

    • Ongoing Z-0720-2023 FDA Class II initiated 7 Nov 2022

    There is a potential for separation at the male connector.

    • Terminated Z-1240-06 FDA Unclassified (pre-2012) initiated 26 Jun 2006

    The tip of the catheter may separate from the body during operation.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
INFINITI™ Diagnostic Catheter/SUPER TORQUE™ Diagnostic Catheter/SUPER TORQUE™ Plus Diagnostic Catheter/TEMPO™ AQUA Diagnostic Catheter EUDAMED
Infiniti GUDID
Generic name
Angiographic catheter, single-use
Model / Ref / Catalog
534-649T EUDAMED
534649T GUDID
Primary DI / UDI-DI
10705032014373
Basic UDI-DI
07050320000000000000052CL
510(k) Number
FDA product code
DQO
EMDN code
C0104010101, C0104020101
GMDN term
Angiographic catheter, single-use
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1200
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
534-649T
GUDID
534649T
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K970854)

Show all (12)

Other devices from Cordis US Corp.

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Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (20)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No