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Traxcess Docking Wire GW14100EX

by Microvention Inc.

Ref GW14100EX

Traxcess Docking Wire GW14100EX is a device classified as Class IIa in the EU and Class II in the US made by Microvention Inc., registered in EUDAMED on 2 Oct 2026 (Basic UDI-DI 08402732TRAXCESSDOCKINGRU), cleared under FDA 510(k) K093647 on 24 Feb 2010 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00840273212102), active as of 25 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093647

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/MDR EUDAMED Number08402732TRAXCESSDOCKINGRU Basic UDI-DI 00840273212102UDI-DIDate2 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00840273212102 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093647 Date24 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08402732TRAXCESSDOCKINGRU registered 2 Oct 2026 Active
  • FDA 510(k) K093647 decided 24 Feb 2010 Active
  • FDA GUDID UDI-DI 00840273212102 listed 24 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093647
  2. Listed FDA GUDID 00840273212102
  3. Registered EUDAMED 08402732TRAXCESSDOCKINGRU

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Traxcess™ Docking Wire EUDAMED
Traxcess Docking Wire GUDID
Generic name
Peripheral vascular guidewire extension
Model / Ref / Catalog
GW14100EX
Primary DI / UDI-DI
00840273212102 EUDAMED
00810170014871 GUDID
Basic UDI-DI
08402732TRAXCESSDOCKINGRU
510(k) Number
FDA product code
DQX
EMDN code
C04020201 Peripheral vascular therapeutic guidewires, hydrophilic
GMDN term
Peripheral vascular guidewire extension
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00840273212102
GUDID
00810170014871
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00840273212102; FDA GUDID lists 00810170014871), 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: Peripheral vascular guidewire extension

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES.

Other devices from Microvention Inc.

See all devices from Microvention Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)