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Arco Progammable Pacemaker System

by Arco Medical Products Co.

510(k) K791147

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 NumberK791147 Date3 Aug 1979ClearedStatusActive

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  • Withdrawn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.

The Arco Programmable Pacemaker System is an implantable pacemaker pulse-generator designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. It delivers electrical impulses to stimulate the heart muscle, ensuring proper heart rate and coordination when the natural pacemaker fails.

This device is intended for surgical implantation by qualified healthcare professionals and is classified as a Class III medical device under 21 CFR 870.3610. It was granted FDA 510(k) clearance (K791147) in 1979 under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Advisory Committee. The system is reusable and requires proper sterilization before use, adhering to regulatory standards for implantable cardiac devices.

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