Maestro Series 100/200 Single Chamber Pacemaker

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

Full name

Maestro(R) Series 100/200 Single Chamber Pacemaker

510(k) Number

K884023 ↗

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 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

• Maestro Model 119 Single-Chamber Pacemaker

  Class III

  FDA 510(k) K880422 Active Cleared 31 Mar 1988

See all devices from Cardiac Control Systems, Inc. →

• What is the primary purpose of the Maestro Series 100/200 Single Chamber Pacemaker, and who is it designed for?

  The Maestro Series 100/200 Single Chamber Pacemaker is designed to regulate heart rhythm by delivering electrical impulses to the heart’s lower chamber (ventricle). It is intended for patients experiencing bradycardia or other conduction disorders that require ventricular pacing. This device is implanted surgically and is classified as an implantable pacemaker.

• Is the Maestro Series 100/200 Single Chamber Pacemaker intended for reuse, or is it meant to be used only once after implantation?

  The device is explicitly described as intended for single-use within the body after surgical implantation. This means it is not designed for removal or reuse, aligning with standard practice for implantable pacemakers.

• How is the regulatory pathway for this device structured, and what does the product code DXY indicate?

  The Maestro Series 100/200 holds an FDA 510(k) clearance (K884023) under the regulatory framework of 21 CFR 870.3610, demonstrating it is classified as substantially equivalent to a predicate device. The product code DXY is an administrative classification used by the FDA for filing purposes and does not describe the device’s clinical indication or function.

• What types of patients or clinical scenarios would this device be considered for, based on its intended use?

  This device is intended for patients with bradycardia (slow heart rate) or other conduction disorders that require ventricular pacing. It is not intended for atrial pacing or other heart rhythm disorders, as it is a single-chamber pacemaker targeting only the ventricle.

• How is the device supplied, and what should clinicians or buyers know about its handling before implantation?

  While the exact packaging details are not specified, the device is sterile (implied by its implantable nature) and intended for single-use only. Clinicians should follow standard sterile surgical protocols for handling and implantation, ensuring no contamination occurs before use.