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CCS Implantable Maestro 106/206/210 Cardiac Pacemaker

by Cardiac Control Systems, Inc.

510(k) K853471

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 NumberK853471 Date24 Feb 1986ClearedStatusActive

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  • Withdrawn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 106/206/210 Cardiac Pacema
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 106/206/210 Cardiac Pacemaker is an implantable pacemaker pulse-generator, designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when necessary. It is intended for patients experiencing bradycardia or other cardiac conduction disorders requiring artificial pacing.

This device is supplied sterile and intended for single-use implantation by qualified medical professionals in a clinical setting. It is classified under product code DXY and regulated under FDA 510(k) clearance (K853471) with a decision of Substantially Equivalent (SESE). The Maestro series includes models 106, 206, and 210, each tailored for specific pacing requirements, and is governed by regulation 870.3610.

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