Maestro Series 200 Implantable Cardiac Pacemaker

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

Full name

Ccs Implantable Maestro Series 200 Cardiac Pacemak

510(k) Number

K853400 ↗

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 200 Cardiac Pacemaker, and how does it function?

  The Maestro Series 200 is designed to treat bradycardia, a condition where the heart beats too slowly, by delivering timed electrical impulses to the heart muscle. It acts as an artificial pacemaker, compensating for dysfunction in the natural conduction system to maintain a proper heart rate and ensure stable cardiac function.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  The device is sterile and intended for single-use only. Due to its implantable nature and regulatory classification, it must be handled and stored according to manufacturer guidelines to prevent contamination or compromise of its sterile integrity.

• How was the regulatory pathway for this device determined, and what type of review process was used?

  The Maestro Series 200 received FDA 510(k) clearance through a traditional review process, with oversight from the Cardiovascular (CV) Advisory Committee. The device was classified as substantially equivalent (SESE) to a predicate, allowing it to follow this established pathway for approval.

• What regulatory category does this pacemaker fall under, and what does that mean for its use?

  This device is classified as a Class III medical device under FDA regulations, which means it carries higher risk and requires strict compliance with manufacturing, labeling, and performance standards. This classification reflects its role as an implantable device critical to life-sustaining cardiac function.