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CCS Implantable Maestro Series 100/200 Pacemaker

by Cardiac Control Systems, Inc.

510(k) K874158

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 NumberK874158 Date29 Dec 1987ClearedStatusActive

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  • Withdrawn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)

Full name
Ccs Implantable Maestro(R) Series 100/200 Pacemak.
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 CCS Implantable Maestro Series 100/200 Pacemaker is an implantable pulse-generator designed for cardiac rhythm management. Classified as an Implantable Pacemaker Pulse-Generator, it is intended to provide electrical stimulation to regulate abnormal heart rhythms in patients with bradycardia or other conduction disorders.

This device is supplied as a reusable, implantable medical implant and is regulated under FDA 510(k) clearance (K874158) with a classification of Class III (DXY). It is intended for use in clinical settings by qualified healthcare professionals and must be implanted surgically. The device adheres to regulatory standards outlined in 870.3610 and is associated with the Cardiovascular specialty. Sterility and single-use requirements are not applicable, as the device is intended for permanent implantation.

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