Maestro Series 100-HEART Pacemaker

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

Full name

Ccs Implantable Maestro Series 100-Heart Pacemaker

510(k) Number

K850384 ↗

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 is the primary clinical purpose of the CCS Implantable Maestro Series 100-Heart Pacemaker, and how does it address patient needs?

  The Maestro Series 100-Heart Pacemaker is designed to provide electrical stimulation to the heart when the body’s natural pacemaker fails to maintain an adequate rhythm. It is specifically intended for patients with bradycardia (slow heart rate) or conduction disorders, delivering timed electrical impulses to sustain a regular cardiac rhythm. This ensures consistent heart function, improving quality of life and reducing symptoms like fatigue or fainting.

• Is the Maestro Series 100-Heart Pacemaker intended for reuse, or is it meant to be implanted as a single-use device?

  The device is explicitly labeled as sterile and intended for single-use only. Due to its implantable nature, it must be professionally installed in a sterile operating environment by a healthcare provider, ensuring patient safety and compliance with medical standards.

• What regulatory pathway was followed for FDA clearance of this pacemaker, and which advisory committee reviewed it?

  The Maestro Series 100-Heart Pacemaker received FDA 510(k) clearance under the traditional review pathway, with a decision classification of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations (product code DXY).

• How many distinct device identifiers (FEI numbers) are associated with this pacemaker model, and what does this indicate about its regulatory history?

  The device has 25 distinct FEI (Facility Device Identification) numbers listed in regulatory records, each corresponding to different manufacturing lots or variants. This indicates a long-standing regulatory history, spanning multiple production runs and compliance filings with the FDA since its clearance in 1985. Each FEI number ensures traceability for quality and safety monitoring.