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Low Profile Lead Connector Modification (4002)

by Medtronic Vascular

510(k) K801284

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801284 Date1 Dec 1980ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DTB
Device class
Class III
Regulation
21 CFR Part 870.3680
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Permanent Pacemaker Electrode, specifically a modification of a lead connector designed to reduce profile while maintaining electrical connectivity. It is intended for use in cardiac pacing systems to facilitate implantation with minimal tissue displacement, improving patient comfort and procedural ease.

The Low Profile Lead Connector Modification (4002) is supplied as a reusable component for pacemaker lead systems and is classified as a Class III device under FDA regulations. It is intended for use in cardiovascular procedures and has received FDA 510K clearance under the Traditional pathway, with a decision code of SESE (Substantially Equivalent). Compliance with regulation number 870.3680 ensures adherence to safety and performance standards for pacemaker electrodes.

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