Maestro II Series 200 Models 235 and 227 Cardiac Pacemaker

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

Full name

Ccs Maestro(R) II Series 200 Models 235 and 227 Cardiac Pacemaker

510(k) Number

K950210 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

ST

• 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

• 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 specific heart conditions is the CCS MAESTRO® II Series 200 (Models 235 and 227) designed to treat, and how does it work?

  The CCS MAESTRO® II Series 200 (Models 235 and 227) is designed to treat patients with bradycardia or other conduction disorders that require chronic cardiac pacing. It works by acting as an implantable pacemaker pulse-generator, delivering controlled electrical impulses to the heart muscle when the natural pacemaker fails to maintain an adequate heart rhythm. This helps regulate and stabilize the heartbeat in patients who rely on artificial pacing for proper cardiac function.

• Is the CCS MAESTRO® II Series 200 (Models 235 and 227) intended for single-use or reusable implantation, and how is it supplied?

  The device is sterile and intended for single-use implantation only, performed by a healthcare professional in a clinical setting. It is not designed for reuse, ensuring patient safety and sterility standards are maintained during implantation.

• What regulatory pathway was followed for FDA clearance of the CCS MAESTRO® II Series 200 (Models 235 and 227), and what does this mean for tracking?

  The device received FDA 510(k) clearance (K950210) under the Traditional 510(k) pathway, with a decision of Substantially Equivalent – Subject to Tracking. This means it was deemed comparable to a previously cleared predicate device but requires additional monitoring by the FDA to ensure continued safety and performance in clinical use.

• Are there different models (235 and 227) within the CCS MAESTRO® II Series 200, and if so, how do they differ in application?

  Models 235 and 227 are both part of the same series but are categorized under the Implantable Pacemaker Pulse-Generator classification for cardiovascular applications. While the exact technical differences between the two models are not specified in the data, they are both regulated under the same FDA product code (DXY) and intended for similar clinical purposes—treating bradycardia or conduction disorders requiring chronic pacing. Further specifications would require consulting the manufacturer’s detailed product documentation.