Cardiophone Implantable Pacemaker Pulse-Generator

by North American Motronic

510(k) K781973

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

510(k) K781973↗

FDA record

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

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK781973	Date21 Mar 1979Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name: Cardiophone

510(k) Number: K781973
FDA Product Code: DXY

Device Class: Class III
Regulation: 21 CFR Part 870.3610
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 Cardiophone is an implantable pacemaker pulse-generator, classified as a Class III medical device under FDA regulations. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to do so, ensuring consistent and appropriate cardiac contractions for patients with bradycardia or other conduction disorders.

This device is intended for surgical implantation by a qualified healthcare professional and is supplied sterile for single-use. It is regulated under FDA 510(k) clearance (K781973) and falls under the product code DXY, adhering to the regulatory requirements for implantable cardiac devices. Storage and handling must comply with sterile medical device protocols to maintain functionality and patient safety.