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Model 435-03 Side Hook Implantable Pacing Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K870948

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK870948 Date10 Apr 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  • Withdrawn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.

The Model 435-03 Side Hook Implantable Pacing Lead is a Permanent Pacemaker Electrode, designed for cardiac pacing applications. It delivers electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, featuring a side hook fixation mechanism for secure anchoring within the heart chamber.

This device is intended for single-use implantation and is classified as a Class III medical device under FDA product code DTB. Supplied sterile and intended for use in cardiac electrophysiology procedures, it requires sterile handling and proper surgical implantation techniques. The Model 435-03 was granted FDA 510(k) clearance (K870948) in 1987 under the Traditional 510(k) review pathway, with regulatory compliance governed by 21 CFR 870.3680.

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