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Nylex 526422

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

None found

in data synced 23 Oct 2026

Documents

510(k) K181836

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 StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK181836 Date8 Aug 2018DecidedStatusActive
United StatesGUDID listing Number10705032010597 UDI-DI Date26 Sep 2017ListedStatusListed GUDID: in commercial distribution

Official records

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Nylex
Generic name
Angiographic catheter, single-use
Model / Ref / Catalog
526422
Primary DI / UDI-DI
10705032010597
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 (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 (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