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Needle

by Argon Medical Devices, Inc. 14 variants

Ref 195350

Needle (195350) 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 24 Apr 2026 (Basic UDI-DI B-10886333208491), cleared under FDA 510(k) K772369 on 24 Jan 1978 and listed in FDA GUDID since 2 Sep 2016 (UDI-DI 10886333208491), active (EUDAMED, FDA 510(k)), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US), not in commercial distribution.

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K772369

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10886333208491 Basic UDI-DI 10886333208491UDI-DIDate24 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10886333208491 UDI-DI Date2 Sep 2016ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK772369 Date24 Jan 1978DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10886333208491 registered 24 Apr 2026 Active
  • FDA 510(k) K772369 decided 24 Jan 1978 Active
  • FDA GUDID UDI-DI 10886333208491 listed 2 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K772369
  2. Listed FDA GUDID 10886333208491
  3. Registered EUDAMED B-10886333208491

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  • Withdrawn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
Needle EUDAMED
Modified Cournand Styled Needle GUDID
Generic name
Vascular catheter introduction needle
Device name
Modified Cournand Needle
Model / Ref / Catalog
195350
Primary DI / UDI-DI
10886333208491 EUDAMED
00886333208494 GUDID
Basic UDI-DI
B-10886333208491
510(k) Number
FDA product code
DRC
EMDN code
C0504, C058099
GMDN term
Vascular catheter introduction needle
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1390
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10886333208491
GUDID
00886333208494
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 10886333208491; FDA GUDID lists 00886333208494), 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.

Manufacturer details

EUDAMED SRN
US-MF-000002324
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS - ACCESSORIES.

Other devices from Argon Medical Devices, Inc.

See all devices from Argon Medical Devices, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)