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Bipolar Pacemaker Model 224

by Intermedics, Inc. 510(k)

Active United States

510(k) K772057

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK772057 Date3 Nov 1977ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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.

The Bipolar Pacemaker Model 224 is an implantable pulse-generator classified as an Implantable Pacemaker under the FDA’s nomenclature. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate rate or rhythm.

This device is intended for surgical implantation and is supplied as a reusable medical device. It is regulated under FDA’s 510(k) pathway with a clearance type designated as Traditional, falling under device class III (DXY). The device is authorized for use in cardiovascular applications and adheres to regulatory requirements outlined in 870.3610.

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