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Doc 22260

by Abbott Vascular

Ref 22260

Doc 22260 is a device classified as Class I in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 8 Sep 2026 (Basic UDI-DI 8717648VAC0001VS), cleared under FDA 510(k) K931171 on 4 Jun 1993 and listed in FDA GUDID since 5 Feb 2016 (UDI-DI 08717648013317), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K931171

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/MDR EUDAMED Number8717648VAC0001VS Basic UDI-DI 08717648013317UDI-DIDate8 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648013317 UDI-DI Date5 Feb 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK931171 Date4 Jun 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8717648VAC0001VS registered 8 Sep 2026 Active
  • FDA 510(k) K931171 decided 4 Jun 1993 Active
  • FDA GUDID UDI-DI 08717648013317 listed 5 Feb 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K931171
  2. Listed FDA GUDID 08717648013317
  3. Registered EUDAMED 8717648VAC0001VS

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  • Withdrawn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
DOC™ Guide Wire Extension EUDAMED
Doc GUDID
Generic name
Coronary artery guidewire extension
Device name
Guide Wire Exchange Devices
Model / Ref / Catalog
22260
Primary DI / UDI-DI
08717648013317
Basic UDI-DI
8717648VAC0001VS
510(k) Number
FDA product code
DQX
EMDN code
C0480 Cardiovascular guidewires - accessories
GMDN term
Coronary artery guidewire extension
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1330
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Coronary artery guidewire extension

Similar devices in this category

Other devices filed under CARDIOVASCULAR GUIDEWIRES - ACCESSORIES.

Other devices from Abbott Vascular

See all devices from Abbott Vascular →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)