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AngioSystems Drape 3003

by Angiosystems, Incorporated

AngioSystems Drape 3003 is a Class II device made by Angiosystems, Incorporated, cleared under FDA 510(k) K843260 on 21 Sep 1984 and listed in FDA GUDID since 16 May 2016 (UDI-DI 00816611020005), active as of 22 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 22 Oct 2026

Documents

510(k) K843260

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00816611020005 UDI-DI Date16 May 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK843260 Date21 Sep 1984DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K843260 decided 21 Sep 1984 Active
  • FDA GUDID UDI-DI 00816611020005 listed 16 May 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K843260
  2. Listed FDA GUDID 00816611020005

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
AngioSystems Drape
Generic name
Angiographic drape
Model / reference
3003
Primary DI / UDI-DI
00816611020005
510(k) Number
FDA product code
KKX
GMDN term
Angiographic drape
Device class
Class II
Regulation number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Category: Angiographic drape

Cleared under the same submission (K843260)

and 8 more cleared under K843260

Other devices from Angiosystems, Incorporated

See all devices from Angiosystems, Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)