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Pacemaker, Antrio-Ventricular Seq.

by American Pacemaker Corp.

510(k) K770328

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 NumberK770328 Date28 Feb 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  • Withdrawn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)

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 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 atria and ventricles in a coordinated sequence, ensuring proper cardiac pacing for patients with conduction system disorders.

The Pacemaker, Atrioventricular Sequential is intended for implantable use and is supplied sterile for single-patient application. It is regulated under FDA 510(k) clearance (K770328) and falls under the Cardiovascular advisory committee category. Compliance with regulation number 870.3610 ensures adherence to safety and performance standards for pacemaker devices.

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