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Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing Lead

by Intermedics, Inc.

510(k) K955122

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)ST Traditional NumberK955122 Date4 Nov 1996DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

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
ST

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 Intermedics Model 436-07 Bipolar and Model 437-07 Unipolar Implantable Endocardial Pacing Lead are classified as Permanent Pacemaker Electrodes. These devices are designed to facilitate electrical conduction between an implantable cardiac pulse generator and the heart muscle, enabling long-term cardiac pacing for ventricular applications.

These leads are intended for single-use implantation and are supplied sterile. They are regulated under FDA 510(k) clearance (K955122) as Class III devices, with a decision of Substantially Equivalent and subject to tracking regulations. The devices are used in cardiovascular settings and comply with regulation number 870.3680.

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