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Maestro Series 100/200 Cardiac Single Chamber Pacemaker

by Cardiac Control Systems, Inc.

510(k) K904941

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 NumberK904941 Date3 Jan 1991ClearedStatusActive

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  • Withdrawn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
Maestro Series 100/200 Cardiac Single Chamber Pace
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 Maestro Series 100/200 is an Implantable Pacemaker Pulse-Generator, designed to provide electrical stimulation to the heart for patients with bradycardia or conduction system disorders. It delivers timed electrical impulses to maintain a consistent heart rhythm in single-chamber pacing applications, ensuring proper cardiac function in eligible patients.

This device is intended for implantable use and is classified as a Class III medical device under FDA regulations (870.3610). Supplied sterile and intended for single-use implantation, it requires surgical placement by a healthcare professional. The device is MRI-unspecified and must be used in accordance with its approved specifications and manufacturer instructions to ensure patient safety and efficacy.

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