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Infiniti 538444

by Cordis Corporation

Ref 538-444

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

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K181836

FDA submission, from GUDID

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 771918 Date1 Jun 2026IssuedStatusActive expires 7 Jul 2029
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK181836 Date8 Aug 2018DecidedStatusActive
United StatesGUDID listing GUDID Number10705032014755 UDI-DI Date18 Sep 2017ListedStatusListed GUDID: in commercial distribution

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

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
538-444 EUDAMED
538444 GUDID
Primary DI / UDI-DI
10705032014755
Basic UDI-DI
07050320000000000000052CL
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 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
538-444
GUDID
538444
Device classEUDAMED
Class III
GUDID
Class II

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K181836)

Show all (12)

Other devices from Cordis US Corp.

See all devices from Cordis US Corp. →

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