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Infiniti 534531T

by Cordis Corporation

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K970854

FDA submission, from GUDID

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 Number10705032013789 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970854 Date30 Sep 1997DecidedStatusActive

Official records

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

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Infiniti
Generic name
Angiographic catheter, single-use
Model / Ref / Catalog
534531T
Primary DI / UDI-DI
10705032013789
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

Related devices

Category: Angiographic catheter, single-use

Cleared under the same submission (K970854)

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 (10)

  • Sterilise before use: No
  • 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