Bipolar Cardiac Pacemaker, Model 110

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

510(k) Number

K861009 ↗

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

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• Is this pacemaker designed for temporary or permanent use in patients, and what conditions does it address specifically?

  The Bipolar Cardiac Pacemaker, Model 110, is intended for chronic (permanent) use in patients with bradycardia or conduction disorders requiring long-term cardiac pacing. It regulates abnormal heart rhythms by delivering electrical impulses to the heart muscle, ensuring consistent contractions when the natural pacemaker fails.

• How is the device supplied, and what precautions should be taken during handling and storage?

  The Model 110 is supplied sterile and intended for single-use implantation only. It must be handled using sterile medical device protocols to prevent contamination. Storage should comply with sterile packaging guidelines to maintain patient safety before use.

• What regulatory pathway was followed for this device, and which advisory committee was involved in its review?

  The Bipolar Cardiac Pacemaker, Model 110, underwent a traditional 510(k) review and was deemed substantially equivalent to a predicate device. The Cardiovascular (CV) Advisory Committee was involved in its evaluation, as indicated by the product code (DXY) and regulatory filings.

• Are there multiple models or sizes available for this pacemaker, or is this a single standardized unit?

  The provided data only references Model 110 explicitly, with no additional models or sizes listed. This suggests it is a standardized unit designed for general use in patients requiring chronic cardiac pacing, though clinical variations may exist based on patient-specific needs.