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Unipolar Programmable Lithium Card. Gen.

by Arco Medical Products Co.

510(k) K801241

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 NumberK801241 Date30 Jun 1980ClearedStatusActive

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  • Withdrawn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, designed to deliver electrical impulses to regulate cardiac rhythm in patients with bradycardia or conduction disorders. It operates on a unipolar configuration, utilizing a lithium-based power source for extended battery life, and incorporates programmable features to adjust pacing parameters.

The device is intended for surgical implantation and is supplied sterile for single-use. It is classified as a Class III medical device under FDA regulations (870.3610) and was granted FDA 510K clearance under the Traditional pathway. Compatible with MRI environments under specific conditions, it requires specialized training for implantation and maintenance, adhering to strict sterility protocols post-manufacture.

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