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Fogarty 160245F

by Becton, Dickinson and Company

Ref 160245F

Fogarty 160245F is a device classified as Class IIa in the EU and Class II in the US made by Becton, Dickinson and Company, registered in EUDAMED on 26 Oct 2026 (Basic UDI-DI 0885403PLNQHREXES), cleared under FDA 510(k) K233619 on 20 May 2024 and listed in FDA GUDID since 4 Sep 2026 (UDI-DI 00885403530596), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K233619

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0885403PLNQHREXES Basic UDI-DI 00885403530596UDI-DIDate26 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885403530596 UDI-DI Date4 Sep 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK233619 Date20 May 2024DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0885403PLNQHREXES registered 26 Oct 2026 Active
  • FDA 510(k) K233619 decided 20 May 2024 Active
  • FDA GUDID UDI-DI 00885403530596 listed 4 Sep 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K233619
  2. Listed FDA GUDID 00885403530596
  3. Registered EUDAMED 0885403PLNQHREXES

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  • Withdrawn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
Fogarty
Generic name
Thrombectomy balloon catheter
Model / Ref / Catalog
160245F
Primary DI / UDI-DI
00885403530596
Basic UDI-DI
0885403PLNQHREXES
510(k) Number
FDA product code
MCW
EMDN code
C010402020701 Manual peripheral thrombectomy and thromboaspiration systems
GMDN term
Thrombectomy balloon catheter
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
870.4875
EU registration type
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Length — 50 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Cleared under the same submission (K233619)

and 5 more cleared under K233619

Similar devices in this category

Other devices filed under PERIPHERAL THROMBECTOMY AND THROMBOASPIRATION SYSTEMS.

Other devices from Becton, Dickinson and Company

See all devices from Becton, Dickinson and Company →

Properties

  • Supplied sterile
  • Single use
  • Contains latex
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)