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Electrode, Pacemaker, Permanent & Temporary

by Intermedics, Inc. 510(k)

Active United States

510(k) K870357

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870357 Date21 May 1987ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • 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

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, classified under FDA’s Device Type DTB, designed for both permanent and temporary cardiac pacing applications. It facilitates electrical stimulation of the heart to regulate rhythm in patients with bradycardia or conduction disorders, ensuring consistent cardiac output through direct myocardial contact.

The electrode is supplied sterile for single-use or reusable configurations, depending on model specifications, and is intended for use in clinical settings such as cardiac catheterization labs or operating rooms. Compliance with FDA’s 510(k) clearance (K870357) and regulation 21 CFR 870.3680 ensures adherence to safety and performance standards. Models vary by reference code (e.g., 3002618605, 1028232) and must be stored per manufacturer instructions to maintain sterility and functionality.

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