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Cardiovascular Permanent Pacemaker Electrode

by Pacesetter Systems 510(k)

Active United States

510(k) K891905

Overview

This device is a Permanent Pacemaker Electrode, a medical implant designed to deliver electrical stimulation to the heart for the treatment of bradycardia or other cardiac conduction disorders. It is intended for chronic use in patients requiring long-term cardiac pacing, providing synchronized contractions to maintain proper heart rhythm.

The electrode is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings such as cardiac catheterization labs or operating rooms. It is classified as a Class III device under FDA regulations (870.3680) and has received FDA 510K clearance as substantially equivalent to predicate devices. Multiple model references are listed, including 3002618605, 3008377825, and others, ensuring compatibility with various pacemaker systems.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK891905 Date5 Jun 1989ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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

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