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Model 438-02 Cardifix Side Hook Implant Pace Lead

by Intermedics, Inc. 510(k)

Active United States

510(k) K872126

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK872126 Date22 Mar 1988ClearedStatusActive

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  • Withdrawn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 438-02 Cardifix Side Hook Implant Pace Lead is a Permanent Pacemaker Electrode, designed for cardiac pacing applications. It features a side hook fixation mechanism to secure the lead within the heart, ensuring stable electrical contact for rhythm regulation in patients requiring pacemaker therapy.

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 proper handling and storage as per manufacturer guidelines. The device holds an FDA 510(k) clearance (K872126) and adheres to regulatory standards outlined in 21 CFR 870.3680 for permanent pacemaker electrodes.

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