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ArcoBiolith Pacemaker Model

by Arco Medical Products Co.

510(k) K780776

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 NumberK780776 Date3 Oct 1978ClearedStatusActive

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  • Withdrawn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 ArcoBiolith Pacemaker Model is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia or other conduction disorders requiring consistent pacing to maintain proper cardiac function.

This device is supplied as a reusable, implantable system and is regulated under FDA 510(k) clearance (K780776) with a decision classification of Substantially Equivalent. It is intended for surgical implantation by qualified healthcare professionals in a sterile operating environment, adhering to cardiovascular device standards (regulation number 870.3610). No MRI safety information or specific size variations are noted in the available data.

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