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Models 432-03 & 433-03 Implantable Pacing Leads

by Intermedics, Inc.

510(k) K890411

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)SESE Substantially Equivalent · Traditional NumberK890411 Date28 Mar 1989ClearedStatusActive

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  • Withdrawn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
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 Models 432-03 & 433-03 Implantable Pacing Leads are classified as Permanent Pacemaker Electrodes, designed for implantation to regulate cardiac rhythm by delivering electrical impulses to the heart. These leads are intended for use in pacemaker systems to stimulate the heart muscle when natural electrical conduction is insufficient.

These leads are supplied sterile for single-use implantation in cardiac electrophysiology procedures. They are regulated under FDA 510(k) clearance (K890411) and fall under product code DTB, adhering to regulation 870.3680. The devices are intended for use in controlled clinical settings, such as hospitals or specialized cardiac centers, and require proper handling and storage as per manufacturer guidelines.

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