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Electrode Leads 030-267 & 030-268

by Telectronics, Inc.

510(k) K832110

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 NumberK832110 Date12 Aug 1983ClearedStatusActive

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  • Withdrawn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 Electrode Leads 030-267 & 030-268 are classified as Permanent Pacemaker Electrodes, designed for use in cardiac pacing systems. These leads facilitate electrical signal transmission between an implanted pulse generator and the heart, enabling synchronized cardiac contraction in patients with bradycardia or other pacing indications.

These leads are supplied sterile and intended for single-use implantation. They are regulated under FDA 510(k) clearance (K832110) as Class 3 devices under product code DTB, adhering to regulation 870.3680. Manufactured by Telectronics, Inc., they are intended for use in cardiovascular procedures and require proper sterile handling and implantation techniques as per medical guidelines.

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