Maestro Series 100 Implantable Cardiac Pacemaker

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Ccs Implantable Maestro Series 100 Cardiac Pacema

510(k) Number

K852435 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• CCS Implantable Maestro Series 100/200 Pacemaker

  Class III

  FDA 510(k) K874158 Active Cleared 29 Dec 1987

• Maestro Series 100/200 Single Chamber Pacemaker

  Class III

  FDA 510(k) K884023 Active Cleared 17 Oct 1988

• Maestro II Series 200 Models 235 and 227 Cardiac Pacemaker

  Class III

  FDA 510(k) K950210 Active Cleared 3 May 1995

• CCS Implantable Maestro 106/206/210 Cardiac Pacemaker

  Class III

  FDA 510(k) K853471 Active Cleared 24 Feb 1986

• CCS Model SJ-103 Implantable Atrial

  Class III

  FDA 510(k) K831529 Active Cleared 30 Jun 1983

• Maestro Series 100/200 Cardiac Single Chamber Pacemaker

  Class III

  FDA 510(k) K904941 Active Cleared 3 Jan 1991

See all devices from Cardiac Control Systems, Inc. →

• What types of patients is the Maestro Series 100 Implantable Cardiac Pacemaker designed to support, and how does it work?

  The Maestro Series 100 is designed for patients with bradycardia or other cardiac conduction disorders that require artificial pacing to maintain proper heart function. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a consistent and effective heartbeat when the patient’s natural conduction system is insufficient.

• Is the device intended for single-use or can it be reused after implantation?

  The Maestro Series 100 is explicitly supplied sterile and intended for single-use implantation only. It is not designed for reuse, and any unused portion must be discarded according to medical device disposal protocols.

• What storage conditions are required for the Maestro Series 100 before use?

  The device must be stored in a controlled environment prior to use, as specified in its regulatory documentation. While exact storage conditions (e.g., temperature, humidity) are not detailed here, proper handling ensures MRI safety compliance and device integrity.

• Does the Maestro Series 100 come in multiple model variants, and if so, how do they differ?

  Yes, the device includes multiple model variants, each registered under separate FDA identifiers (e.g., FEI numbers). While the exact specifications of each variant are not provided, they all adhere to MRI safety standards for cardiac pacemakers, ensuring compatibility with magnetic resonance imaging procedures.

• How was the regulatory clearance for this device obtained, and what does that mean for clinicians?

  The Maestro Series 100 received FDA 510(k) clearance through the Traditional pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the device was evaluated by the FDA’s Cardiovascular (CV) Advisory Committee and deemed comparable in safety and effectiveness to existing pacemakers, ensuring it meets established regulatory standards for use in clinical settings.