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CCDS Maestro II Series 200 Cardiac Pacemaker

by Cardiac Control Systems, Inc.

510(k) K946188

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 NumberK946188 Date15 May 1995DecidedStatusActive

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  • Withdrawn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
Ccds Maestro(R) II Series 200 Cadiac Pacemaker
510(k) Number
FDA Product Code
DXY
Device Class
Class III
Regulation
21 CFR Part 870.3610
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 CCDS Maestro II Series 200 Cardiac Pacemaker is an implantable pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. Classified as an Implantable Pacemaker Pulse-Generator, it is intended for patients with bradycardia or other cardiac conduction disorders requiring consistent pacing support.

This device is supplied as a single-use, sterile implantable system and is regulated under FDA 510(k) clearance (K946188) as substantially equivalent with tracking requirements. It is intended for cardiovascular use and falls under the medical specialty of cardiology, adhering to regulatory standards outlined in 21 CFR 870.3610. Multiple model variants are listed under FEI numbers, ensuring compliance with U.S. regulatory requirements for implantable cardiac devices.

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