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Bis/Blv-4402

by Oscor Inc.

Ref BIS/BLV-4402

Bis/Blv-4402 is a device classified as Class III in the EU and Class II in the US made by Oscor Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00885672003692), cleared under FDA 510(k) K925168 on 3 May 1994 and listed in FDA GUDID since 16 Oct 2015 (UDI-DI 00885672003692), active as of 7 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K925168

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/MDD EUDAMED NumberB-00885672003692 Basic UDI-DI 00885672003692UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672003692 UDI-DI Date16 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK925168 Date3 May 1994DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885672003692 registered 30 Oct 2026 Active
  • FDA 510(k) K925168 decided 3 May 1994 Active
  • FDA GUDID UDI-DI 00885672003692 listed 16 Oct 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K925168
  2. Listed FDA GUDID 00885672003692
  3. Registered EUDAMED B-00885672003692

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  • Withdrawn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
Adaptor EUDAMED
Bis/Blv-4402 GUDID
Generic name
Pacing/defibrillation lead electrical adaptor
Model / Ref / Catalog
BIS/BLV-4402
Primary DI / UDI-DI
00885672003692
Basic UDI-DI
B-00885672003692
510(k) Number
FDA product code
DTD
EMDN code
J01900180 Permanent cardiac leads - accessories
GMDN term
Pacing/defibrillation lead electrical adaptor
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.3620
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
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: Pacing/defibrillation lead electrical adaptor

Cleared under the same submission (K925168)

and 8 more cleared under K925168

Similar devices in this category

Other devices filed under PERMANENT CARDIAC LEADS - ACCESSORIES.

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)