Maestro Series 100/200 Cardiac S/Chamb Pacemaker

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

Full name

Maestro(R) Series 100/200 Cardiac S/Chamb Pacemake

510(k) Number

K905824 ↗

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 purpose of the Maestro Series 100/200 Cardiac S/Chamb Pacemaker, and which patients would benefit from it?

  The Maestro Series 100/200 Cardiac S/Chamb Pacemaker is designed to regulate abnormal heart rhythms by delivering electrical impulses to stimulate the heart muscle. It is intended for patients with bradycardia (slow heart rate) or conduction system disorders, ensuring proper cardiac pacing to maintain a healthy heart rhythm.

• Is the Maestro Series 100/200 Pacemaker intended for single-use or reusable applications, and how should it be handled?

  The device is supplied sterile and intended for single-patient use only. Due to its sterile packaging and implantable nature, it must be handled in sterile conditions prior to implantation to prevent contamination.

• What regulatory pathway was followed for the Maestro Series 100/200 Cardiac Pacemaker, and which committee reviewed it?

  The Maestro Series 100/200 Cardiac Pacemaker was reviewed by the Cardiovascular (CV) Advisory Committee under the FDA’s 510(k) clearance process. It was determined to be substantially equivalent to a predicate device, with clearance type labeled as 'Traditional.' The device is classified under product code DXY and regulated under 21 CFR 870.3610.

• Are there any specific storage instructions or considerations for the Maestro Series 100/200 Pacemaker before implantation?

  While the data does not specify detailed storage instructions, the device is sterile and intended for single-patient use. It should be stored in its original packaging until ready for use, ensuring it remains uncontaminated and protected from environmental factors until implantation.