Ccs Model BV-114 Implantable Endocardial Bipolarpa

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

510(k) Number

K853294 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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 CCS Model BV-114 and how is it used in clinical practice?

  The CCS Model BV-114 is an implantable endocardial bipolar pacemaker electrode designed for direct contact with the heart’s inner lining (endocardium) to deliver precise electrical stimulation. It is intended for surgical implantation within a heart chamber—typically accessed via a venous approach—to provide long-term cardiac pacing support for patients requiring rhythm management. This ensures reliable pacing for conditions like bradycardia or heart block.

• Is the BV-114 meant for single-use or can it be reused after sterilization?

  The BV-114 is explicitly supplied sterile for single-use only. Since it is classified as a permanent pacemaker electrode, reuse is not recommended or supported by the manufacturer, and adherence to sterile medical device protocols is required to maintain integrity before implantation.

• What storage and handling requirements must be followed for the BV-114 to ensure sterility?

  The BV-114 must be stored and handled according to sterile medical device protocols to preserve its integrity. Since it is supplied sterile for single-use, it should remain in its original packaging until immediately before use, and any exposure to non-sterile environments should be avoided to prevent contamination.

• How is the BV-114 regulated, and what does its FDA clearance status indicate?

  The BV-114 is regulated under FDA 510(k) clearance (K853294) as a Class III device under regulation 870.3680, classified as a permanent pacemaker electrode. The clearance indicates it is deemed *substantially equivalent* to a legally marketed predicate device, meeting cardiovascular specialty standards for safety and effectiveness in cardiac pacing applications.

• What types of patients or clinical scenarios is the BV-114 intended for?

  While the BV-114 is designed for surgical implantation within heart chambers to deliver pacing stimulation, its specific clinical indications are not detailed in the provided data. However, it is intended for patients requiring long-term cardiac rhythm management, such as those with bradycardia or conduction disorders. The device is not described for acute or temporary use but rather for permanent pacing solutions.