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POINTER™ Nitinol Guidewire 180418260

by Argon Medical Devices, Inc.

Ref 180418260

POINTER™ Nitinol Guidewire 180418260 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 2 Jul 2026 (Basic UDI-DI B-20886333000740), cleared under FDA 510(k) K031442 on 13 Aug 2003 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 20886333000740), active as of 23 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 found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K031442

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-20886333000740 Basic UDI-DI 20886333000740UDI-DIDate2 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number20886333000740 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK031442 Date13 Aug 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-20886333000740 registered 2 Jul 2026 Active
  • FDA 510(k) K031442 decided 13 Aug 2003 Active
  • FDA GUDID UDI-DI 20886333000740 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K031442
  2. Listed FDA GUDID 20886333000740
  3. Registered EUDAMED B-20886333000740

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  • Withdrawn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
Peripheral Guidewires EUDAMED
POINTER™ Nitinol Guidewire GUDID
Generic name
General-purpose non-vascular guidewire
Device name
Guidewires
Model / Ref / Catalog
180418260
Primary DI / UDI-DI
20886333000740 EUDAMED
00886333000746 GUDID
Basic UDI-DI
B-20886333000740
510(k) Number
FDA product code
DQX
EMDN code
A060299, C04020102
GMDN term
General-purpose non-vascular guidewire
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1330
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
20886333000740
GUDID
00886333000746
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 20886333000740; FDA GUDID lists 00886333000746), 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: General-purpose non-vascular guidewire

Cleared under the same submission (K031442)

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC.

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)