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Lead Adaptor 664402-303

by Oscor Inc.

Lead Adaptor 664402-303 (BIS/BLV-4402) is a Class II device made by Oscor Inc., cleared under FDA 510(k) K024156 on 14 Jan 2003 and listed in FDA GUDID since 24 Jul 2026 (UDI-DI 00885672013189), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K024156

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885672013189 UDI-DI Date24 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK024156 Date14 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024156 decided 14 Jan 2003 Active
  • FDA GUDID UDI-DI 00885672013189 listed 24 Jul 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024156
  2. Listed FDA GUDID 00885672013189

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lead Adaptor
Generic name
Pacing/defibrillation lead electrical adaptor
Model / Ref / Catalog
664402-303, BIS/BLV-4402
Primary DI / UDI-DI
00885672013189
510(k) Number
FDA product code
DTD
GMDN term
Pacing/defibrillation lead electrical adaptor
Device class
Class II
Regulation number
870.3620
GUDID distribution status
In Commercial Distribution
Size
Length — 17 Centimeter

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 (7, all answered No)