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Cordis 502191

by Cordis US Corp.

Cordis 502191 is a Class II device made by Cordis US Corp., cleared under FDA 510(k) K914352 on 22 Nov 1991 and listed in FDA GUDID since 26 Sep 2017 (UDI-DI 10705032009621), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K914352

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705032009621 UDI-DI Date26 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK914352 Date22 Nov 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K914352 decided 22 Nov 1991 Active
  • FDA GUDID UDI-DI 10705032009621 listed 26 Sep 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K914352
  2. Listed FDA GUDID 10705032009621

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Cordis
Generic name
Haemostasis valve
Model / Ref / Catalog
502191
Primary DI / UDI-DI
10705032009621
510(k) Number
FDA product code
DYB
GMDN term
Haemostasis valve
Device class
Class II
Regulation number
870.1340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Haemostasis valve

Cleared under the same submission (K914352)

Similar devices in this category

Other devices filed under Haemostasis valve.

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, all answered No)