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Cardiac Pacing Electrode

by Medi-Dyne Instruments, Inc.

510(k) K792379

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 NumberK792379 Date5 Dec 1979ClearedStatusActive

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  • Withdrawn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 under FDA regulation 870.3680. It is designed to deliver electrical impulses to the heart muscle to regulate and maintain an appropriate heart rhythm in patients with bradycardia or conduction system disorders.

The Cardiac Pacing Electrode is intended for single-use implantation in cardiac pacing procedures. It is supplied sterile and requires surgical placement by a qualified healthcare professional. The device is regulated under FDA 510(k) clearance (K792379) and falls under the DTB product code, with a classification as a Class 3 medical device.

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 this Cardiac Pacing Electrode, and how does it function in the body?

    This device is designed to deliver controlled electrical impulses directly to the heart muscle, helping to regulate and maintain a proper heart rhythm. It is specifically intended for patients with bradycardia (slow heart rate) or conduction system disorders, ensuring the heart beats at an appropriate pace to support normal cardiac function.

  • Is this device meant for repeated use, or is it intended for single-use implantation only?

    The Cardiac Pacing Electrode is explicitly intended for single-use implantation during cardiac pacing procedures. Once implanted, it is not designed for removal or reuse, and it must be placed surgically by a qualified healthcare professional.

  • How is this device supplied, and what precautions should be taken during handling?

    The device is supplied sterile to ensure safety and sterility during implantation. Since it is intended for surgical use, it must be handled in a sterile environment, and only trained medical professionals should perform the procedure to avoid contamination or improper placement.

  • What regulatory pathway was followed for this device’s approval, and which committee reviewed it?

    This Cardiac Pacing Electrode was cleared through the FDA’s 510(k) process under the Traditional pathway, with a determination of Substantially Equivalent (SESE) to a predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class 3 medical device under FDA regulation 870.3680.