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Lead Adaptor 664402-302

by Oscor Inc.

Ref BIS/BLV-4402

Lead Adaptor 664402-302 (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-00885672008321), cleared under FDA 510(k) K024156 on 14 Jan 2003 and listed in FDA GUDID since 15 Nov 2017 (UDI-DI 00885672008321), 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) K024156

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-00885672008321 Basic UDI-DI 00885672008321UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672008321 UDI-DI Date15 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK024156 Date14 Jan 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885672008321 registered 30 Oct 2026 Active
  • FDA 510(k) K024156 decided 14 Jan 2003 Active
  • FDA GUDID UDI-DI 00885672008321 listed 15 Nov 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K024156
  2. Listed FDA GUDID 00885672008321
  3. Registered EUDAMED B-00885672008321

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  • Withdrawn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
Lead Adaptor GUDID
Generic name
Pacing/defibrillation lead electrical adaptor
Model / Ref / Catalog
BIS/BLV-4402, 664402-302
Primary DI / UDI-DI
00885672008321
Basic UDI-DI
B-00885672008321
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
Size
Length — 17 Centimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BIS/BLV-4402
GUDID
664402-302
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 (K024156)

and 3 more cleared under K024156

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)