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Telectronics #030-253 Bifurcated

by William C. Nealon

510(k) K831303

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 NumberK831303 Date25 May 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  • Withdrawn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.

This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for implantation within the cardiovascular system to provide electrical stimulation for pacing purposes, ensuring proper heart rhythm in patients with bradycardia or other conduction disorders. The bifurcated design allows for dual lead attachment, facilitating precise electrode positioning within the heart chambers.

The Teletronics #030-253 is supplied sterile and intended for single-use implantation by qualified healthcare professionals in a controlled clinical setting. It is regulated under FDA 510(k) clearance (K831303) and adheres to the regulatory requirements outlined in 21 CFR 870.3680. Storage and handling must comply with sterile medical device protocols to maintain integrity prior to use.

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 purpose of the Teletronics #030-253 Bifurcated device, and how does its design benefit patients?

    The Teletronics #030-253 is a permanent pacemaker electrode designed to maintain proper heart rhythm in patients with bradycardia or conduction disorders by delivering electrical stimulation. Its bifurcated design allows for dual lead attachment, enabling precise electrode positioning within the heart chambers, which enhances pacing accuracy and stability for patients requiring synchronized stimulation.

  • Is this device intended for reuse, or is it meant to be implanted once and discarded?

    The Teletronics #030-253 is sterile and intended for single-use only. It must be implanted by qualified healthcare professionals in a controlled clinical setting, and proper sterile handling protocols must be followed to ensure device integrity before use. Reuse is not recommended or supported by the manufacturer.

  • How should this device be stored to maintain its sterility and functionality before implantation?

    Since the Teletronics #030-253 is supplied sterile, it must be stored according to standard sterile medical device protocols. This includes keeping it in its original packaging, in a clean, dry environment, and away from direct sunlight or extreme temperatures. Always verify the sterility indicators before use to ensure the device remains uncontaminated.

  • What regulatory pathway does this device follow, and which FDA requirements does it comply with?

    The Teletronics #030-253 is classified as a Class III medical device under FDA regulations and has received 510(k) clearance (K831303). It adheres to the requirements outlined in 21 CFR 870.3680, ensuring compliance with FDA standards for permanent pacemaker electrodes. The device was reviewed by the Cardiovascular (CV) Advisory Committee and determined to be substantially equivalent to a predicate device.