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Model 493-01 Pacing Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K844263

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844263 Date28 Mar 1985ClearedStatusActive

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  • Withdrawn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 493-01 Pacing Lead is a permanent pacemaker electrode designed for cardiac pacing applications. It delivers electrical impulses to stimulate the heart muscle, ensuring proper rhythm and function in patients with bradycardia or conduction system disorders.

This device is intended for implantable use within the cardiovascular system and is supplied sterile for single-use implantation. The connector pin, made of 316 stainless steel, ensures reliable electrical and mechanical coupling with the pulse generator. Authorized under FDA 510(k) clearance (K844263) as a Class III device under regulation 870.3680, it adheres to strict cardiovascular medical specialty standards.

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