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Preface 301803P

by Biosense Webster Inc

Ref 301803PModel PREFACE

Preface 301803P is a vascular catheter introduction set (EU MDR Class III; FDA Class II; FDA product code DYB, Introducer, Catheter) made by Biosense Webster Inc, registered in EUDAMED on 5 Jan 2026 (Basic UDI-DI 08468350a0029FD), cleared under FDA 510(k) K982740 on 28 Aug 1998 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10846835000054), active as of 9 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

16 May 2029

CE MDR certificate

FDA recalls

None found

in data synced 9 Nov 2026

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

510(k) K982740

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/MDR EUDAMED Number08468350a0029FD Basic UDI-DI 10846835000054UDI-DIDate5 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10846835000054 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK982740 Date28 Aug 1998DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08468350a0029FD registered 5 Jan 2026 Active
  • FDA 510(k) K982740 decided 28 Aug 1998 Active
  • FDA GUDID UDI-DI 10846835000054 listed 16 Sep 2016 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 787990 Active Amended

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    16 May 2025
    Expires
    16 May 2029
    Reason
    Other

Timeline

3 dated events

  1. Cleared FDA 510(k) K982740
  2. Listed FDA GUDID 10846835000054
  3. Registered EUDAMED 08468350a0029FD

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  • Withdrawn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
PREFACE Sheath EUDAMED
Preface GUDID
Generic name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
301803P, PREFACE
Primary DI / UDI-DI
10846835000054
Basic UDI-DI
08468350a0029FD
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
Standard device
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

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 (K982740)

Similar devices in this category

Other devices filed under CARDIOVASCULAR INTRODUCER SHEATHS, VALVED.

Other devices from Biosense Webster Inc

See all devices from Biosense Webster Inc →

Properties

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