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Slimline Unipolar Endocardial Pacing Lead, 030-438

by Telectronics, Inc.

510(k) K865098

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 NumberK865098 Date18 Aug 1987ClearedStatusActive

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  • Withdrawn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 Slimline Unipolar Endocardial Pacing Lead, 030-438, is a Permanent Pacemaker Electrode designed for endocardial pacing applications. It is a unipolar lead intended for implantation within the heart to stimulate cardiac contractions, aiding patients with bradycardia or conduction disorders.

This device is supplied sterile and intended for single-use implantation in cardiac electrophysiology settings. It is classified as a Class 3 Cardiovascular device under FDA product code DTB and was cleared via the Traditional 510(k) pathway. The lead is regulated under FDA regulation number 870.3680 and is associated with registration numbers and FEI identifiers listed in the OpenFDA database.

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