Maestro II Series 200 Cardiac Pacemaker

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

Full name

Ccs Maestro II Series 200 Cardiac Pacemaker

510(k) Number

K923868 ↗

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 Maestro II Series 200 Cardiac Pacemaker, and how does it function in the body?

  The Maestro II Series 200 Cardiac Pacemaker is designed to regulate heart rhythm in patients with bradycardia or conduction system disorders. It delivers controlled electrical impulses to stimulate the heart muscle when the natural pacemaker fails, ensuring consistent cardiac output and preventing life-threatening arrhythmias. This device is implanted by qualified healthcare professionals to maintain proper heart function.

• Is the CCS Maestro II Series 200 Cardiac Pacemaker intended for single-use or can it be reused after sterilization?

  The device is explicitly labeled as single-use and intended for implantable use in clinical settings. It requires proper handling and storage per manufacturer guidelines, and reuse is not authorized or recommended.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it fall under?

  The CCS Maestro II Series 200 Cardiac Pacemaker was authorized under the FDA 510(k) clearance process (K923868) and is classified as a Class III medical device under the product code DXY. This classification aligns with its role as an Implantable Pacemaker Pulse-Generator, adhering to stringent regulatory standards for cardiovascular applications.

• How should the device be stored to maintain its integrity before implantation?

  While specific storage instructions are not detailed in the provided data, the device is single-use and requires proper handling per manufacturer guidelines. It should be stored in a clean, dry environment, protected from physical damage, and kept within its expiration date to ensure sterility and functionality before use.