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AFP Cardiac Pacing System Model 283 (Modification)

by Pacesetter, Inc.

510(k) K954714

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)ST Traditional NumberK954714 Date1 Feb 1996DecidedStatusActive

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  • Withdrawn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
ST

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 AFP Cardiac Pacing System Model 283 (Modification) is a Permanent Pacemaker Electrode, designed to provide electrical stimulation for cardiac pacing in patients with bradycardia or conduction system disorders. It delivers timed electrical impulses to regulate heart rhythm, ensuring proper cardiac function in individuals requiring long-term pacing support.

This system is intended for use in clinical settings by trained healthcare professionals, adhering to standard sterile procedures for implantation. Supplied as a reusable device with specific model variants, it is classified under FDA 510(k) clearance and regulated under device classification 3, with a primary application in cardiovascular medicine. Storage and handling follow manufacturer guidelines to maintain device integrity and performance.

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