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Model 495-01 Pacing Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K844265

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK844265 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  • Withdrawn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 495-01 Pacing Lead is a permanent pacemaker electrode, classified under FDA regulation 870.3680 as a Class III device. It is designed to deliver electrical impulses to the heart for pacing purposes, ensuring proper cardiac rhythm in patients requiring chronic cardiac stimulation.

This device is intended for single-use implantation within a clinical setting and is regulated under the FDA’s 510(k) pathway with clearance number K844265. Supplied sterile, it is intended for use in cardiovascular procedures and adheres to the requirements of the Cardiovascular advisory committee. No additional storage or handling specifications are provided beyond standard sterile medical device protocols.

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