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Endocardial Pacing Lead, Model 476-01

by Intermedics, Inc. 510(k)

Active United States

510(k) K790548

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790548 Date1 Jun 1979ClearedStatusActive

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  • Withdrawn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 Endocardial Pacing Lead, Model 476-01, is a permanent pacemaker electrode designed for transvenous placement within the heart. It delivers electrical stimulation to regulate cardiac rhythm in patients with bradycardia or conduction disorders, ensuring proper pacing of the heart chambers.

This device is intended for single-use implantation and is supplied sterile. It is classified as a Class III medical device under FDA regulations (21 CFR 870.3680) and holds a Traditional 510(k) clearance (K790548) with a decision of Substantially Equivalent. Compatible with MRI environments under specific conditions, it is distributed in sterile packaging for surgical use in cardiovascular procedures.

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