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Lifeline Endocardial Pacing Lead #479-05

by Intermedics, Inc. 510(k)

Active United States

510(k) K830782

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK830782 Date18 Apr 1983ClearedStatusActive

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  • Withdrawn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 Lifeline Endocardial Pacing Lead #479-05 is a permanent pacemaker electrode designed for endocardial pacing. This device delivers electrical impulses to the heart muscle to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring proper heart function through direct contact with the endocardium.

This lead is intended for use in cardiac electrophysiology procedures, supplied sterile for single-use implantation. It is classified as a Class III device under FDA regulations and requires professional medical expertise for placement. The device is authorized under an FDA 510(k) clearance (K830782) and adheres to the regulatory standards outlined in 21 CFR 870.3680 for permanent pacemaker electrodes.

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