Skip to content

Arterial Extensions 041115002A

by Argon Medical Devices, Inc.

Ref 041115002A

Arterial Extensions 041115002A is a device classified as Class IIa in the EU and Class II in the US made by Argon Medical Devices, Inc., registered in EUDAMED on 11 Jun 2026 (Basic UDI-DI B-20886333201352), cleared under FDA 510(k) K780271 on 2 Mar 1978 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 20886333201352), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K780271

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20886333201352 Basic UDI-DI 20886333201352UDI-DIDate11 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333201352 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK780271 Date2 Mar 1978DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20886333201352 registered 11 Jun 2026 Active
  • FDA 510(k) K780271 decided 2 Mar 1978 Active
  • FDA GUDID UDI-DI 20886333201352 listed 9 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0290-2020 FDA Class II initiated 16 Oct 2018 on shared 510(k) K780271

    The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K780271
  2. Listed FDA GUDID 20886333201352
  3. Recall initiated FDA recalls Z-0290-2020
  4. Registered EUDAMED B-20886333201352

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Arterial Extensions Line EUDAMED
Arterial Extensions GUDID
Generic name
Intravenous line stopcock
Model / Ref / Catalog
041115002A
Primary DI / UDI-DI
20886333201352 EUDAMED
00886333201358 GUDID
Basic UDI-DI
B-20886333201352
510(k) Number
FDA product code
DTL
EMDN code
A0680 Drainage and fluid collection devices - accessories
GMDN term
Intravenous line stopcock
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4290
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
20886333201352
GUDID
00886333201358
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333201352; FDA GUDID lists 00886333201358), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Intravenous line stopcock

Cleared under the same submission (K780271)

and 5 more cleared under K780271

Similar devices in this category

Other devices filed under DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)