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Electrode, Pacemaker Permanent

by Pacesetter Systems 510(k)

Active United States

510(k) K810582

Overview

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the heart to deliver electrical impulses that regulate cardiac rhythm in patients with bradycardia or other conduction disorders, ensuring proper heart function and stability.

The electrode is intended for single-use implantation and is supplied sterile, requiring surgical placement by a qualified healthcare professional. It is regulated under FDA 510(k) clearance (K810582) and adheres to the Permanent Pacemaker Electrode nomenclature (DTB product code). Multiple model references are listed, including 3002618605, 3008377825, and others, ensuring compatibility with various pacemaker systems. Storage and handling must comply with sterile medical device protocols.

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 NumberK810582 Date13 Mar 1981ClearedStatusActive

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  • Withdrawn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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