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Torque Device 22215

by Abbott Vascular

Ref 22215

Torque Device 22215 is a device classified as Class I in the EU and Class II in the US made by Abbott Vascular, registered in EUDAMED on 9 Oct 2026 (Basic UDI-DI B-08717648013294), cleared under FDA 510(k) K950752 on 15 May 1995 and listed in FDA GUDID since 5 Aug 2016 (UDI-DI 08717648013294), active as of 24 Oct 2026. One FDA recall is linked to it.

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) K950752

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08717648013294 Basic UDI-DI 08717648013294UDI-DIDate9 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08717648013294 UDI-DI Date5 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK950752 Date15 May 1995DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08717648013294 registered 9 Oct 2026 Active
  • FDA 510(k) K950752 decided 15 May 1995 Active
  • FDA GUDID UDI-DI 08717648013294 listed 5 Aug 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-2791-2011 FDA Unclassified (pre-2012) initiated 7 Jan 2011

    Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO sterilization.

Timeline

4 dated events

  1. Cleared FDA 510(k) K950752
  2. Recall initiated FDA recalls Z-2791-2011
  3. Listed FDA GUDID 08717648013294
  4. Registered EUDAMED B-08717648013294

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  • Withdrawn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
Torque Device
Generic name
Torque manipulation device
Model / Ref / Catalog
22215
Primary DI / UDI-DI
08717648013294
Basic UDI-DI
B-08717648013294
510(k) Number
FDA product code
DQX
EMDN code
C0480 Cardiovascular guidewires - accessories
GMDN term
Torque manipulation device
Device class
Class I 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 · 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: Torque manipulation device

Cleared under the same submission (K950752)

and 1 more cleared under K950752

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)