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100 cm Permanent Pacing Lead Models

by Telectronics Pacing Systems, Inc.

510(k) K911273

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 NumberK911273 Date28 Aug 1991ClearedStatusActive

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  • Withdrawn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.

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It delivers electrical stimulation to the heart to regulate rhythm in patients with bradyarrhythmias, ensuring consistent cardiac pacing through a 100 cm lead designed for long-term implantation.

The 100 cm Permanent Pacing Lead Models are intended for single-use implantation in cardiac pacing systems, adhering to FDA 510(k) clearance (K911273) under the DTB product code. Supplied sterile and intended for use in clinical settings, these leads are regulated under 870.3680 and distributed by Telectronics Pacing Systems, Inc. No MRI safety or reusable specifications are noted in the regulatory data.

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Questions

AI-generated answers, 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.

  • What is the primary clinical purpose of the 100 cm Permanent Pacing Lead Models from Telectronics Pacing Systems, Inc.?

    The 100 cm Permanent Pacing Lead Models are designed to deliver electrical stimulation to the heart for patients with bradyarrhythmias, ensuring consistent cardiac pacing through long-term implantation. They are intended for use in cardiac pacing systems to regulate heart rhythm.

  • Are these leads meant for single-use or can they be reused after implantation?

    These leads are explicitly intended for single-use implantation only, as stated in the regulatory data. They are supplied sterile and are not designed for reuse.

  • What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?

    The device followed the Traditional 510(k) pathway and was reviewed by the Cardiovascular (CV) Advisory Committee. It was determined to be Substantially Equivalent (SESE) to a predicate device, with clearance granted under product code DTB and regulation 870.3680.

  • How are these leads supplied, and what should clinicians consider regarding sterility?

    The leads are supplied sterile and intended for clinical use. Since they are single-use, clinicians should ensure proper handling and adherence to sterile techniques during implantation to maintain integrity and safety.

  • Are there any specific storage requirements mentioned for these leads?

    The regulatory data does not explicitly detail storage conditions, but as a sterile, single-use medical device, it is standard practice to store these leads in a clean, dry environment away from direct sunlight or extreme temperatures until use. Always follow manufacturer guidelines for optimal preservation.