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Fast-Cath™ 406886

by St. Jude Medical, Inc.

Ref 406886

Fast-Cath 406886 is a vascular catheter introduction set (EU MDD Class III; FDA Class II; FDA product code DYB, Introducer, Catheter) made by St. Jude Medical, Inc., registered in EUDAMED on 28 Aug 2026 (Basic UDI-DI B-05414734203104), cleared under FDA 510(k) K061015 on 3 Aug 2006 and listed in FDA GUDID since 11 Apr 2015 (UDI-DI 05414734203104), active as of 9 Nov 2026.

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 found

in data synced 9 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K061015

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05414734203104 Basic UDI-DI 05414734203104UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05414734203104 UDI-DI Date11 Apr 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK061015 Date3 Aug 2006DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-05414734203104 registered 28 Aug 2026 Active
  • FDA 510(k) K061015 decided 3 Aug 2006 Active
  • FDA GUDID UDI-DI 05414734203104 listed 11 Apr 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K061015
  2. Listed FDA GUDID 05414734203104
  3. Registered EUDAMED B-05414734203104

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  • Withdrawn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
Fast-Cath™
Generic name
Vascular catheter introduction set, nonimplantable
Device name
Fast-Cath Guiding Introducers
Model / Ref / Catalog
406886
Primary DI / UDI-DI
05414734203104
Basic UDI-DI
B-05414734203104
510(k) Number
FDA product code
DYB
EMDN code
C0502 Cardiovascular introducer sheaths, valved
GMDN term
Vascular catheter introduction set, nonimplantable
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.1340
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Size
Catheter Gauge — 8 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III 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: Vascular catheter introduction set, nonimplantable

Cleared under the same submission (K061015)

and 8 more cleared under K061015

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from St. Jude Medical, Inc.

See all devices from St. Jude Medical, Inc. →

Properties

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