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Pulse Generator, Unipolar, #508

by Cardiac Pacemakers, Inc.

510(k) K770880

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 NumberK770880 Date20 Jun 1977ClearedStatusActive

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  • Withdrawn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)

Full name
Generator, Pulse, Unipolar, #508
510(k) Number
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.

This device is an implantable pulse generator, classified as a unipolar type, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It falls under the nomenclature of an Implantable Pacemaker Pulse-Generator, providing pacing therapy for patients with bradycardia or other cardiac conduction disorders.

The Pulse Generator, Unipolar, #508 is intended for surgical implantation and is regulated under FDA 510(k) clearance with a decision classification of Substantially Equivalent. It is supplied sterile and intended for single-use implantation, adhering to Class III medical device standards (DXY) and regulatory requirements outlined in 21 CFR 870.3610. Authorized by Cardiac Pacemakers, Inc., it is distributed for use in cardiovascular settings.

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