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ClosureFast™ CF6-8-60

by Medtronic, Inc.

Ref CF6-8-60

ClosureFast CF6-8-60 is a peripheral vascular electrocautery catheter (EU MDR Class IIb; FDA Class II; FDA product code GEI, Electrosurgical, cutting & coagulation & accessories) made by Medtronic, Inc., registered in EUDAMED on 27 May 2026 (Basic UDI-DI 0763000B00004057C), cleared under FDA 510(k) K223488 on 23 Mar 2023 and listed in FDA GUDID since 16 Jun 2023 (UDI-DI 00763000552169), 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) K223488

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 Number0763000B00004057C Basic UDI-DI 00763000552169UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000552169 UDI-DI Date16 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK223488 Date23 Mar 2023DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00004057C registered 27 May 2026 Active
  • FDA 510(k) K223488 decided 23 Mar 2023 Active
  • FDA GUDID UDI-DI 00763000552169 listed 16 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K223488
  2. Listed FDA GUDID 00763000552169
  3. Registered EUDAMED 0763000B00004057C

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  • Withdrawn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
ClosureFast™
Generic name
Peripheral vascular electrocautery catheter, single-use
Device name
ClosureFast Catheter
Model / reference
CF6-8-60
Primary DI / UDI-DI
00763000552169
Basic UDI-DI
0763000B00004057C
510(k) Number
FDA product code
GEI
EMDN code
C0190190401 Catheters for radiofrequency endovenous ablation
GMDN term
Peripheral vascular electrocautery catheter, single-use
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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 electrocautery catheter, single-use

Cleared under the same submission (K223488)

Similar devices in this category

Other devices filed under SYSTEMS FOR VESSEL EXTRACTION AND VEIN CLOSURE.

Other devices from Medtronic, Inc.

See all devices from Medtronic, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)