CCS Model AV-102 Implantable A-V Data

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

510(k) Number

K834342 ↗

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 AV-102 Implantable A-V Data device, and how does it function in the body?

  The CCS Model AV-102 is a permanent pacemaker electrode designed to monitor and regulate atrioventricular (A-V) conduction. It acts as a conductive pathway between an implanted pacemaker pulse generator and the heart, transmitting electrical signals to help maintain proper heart rhythm in patients with cardiac rhythm disorders. Essentially, it ensures the atria and ventricles coordinate effectively during contractions.

• Is the CCS Model AV-102 intended for reuse, or is it meant to be implanted as a single-use device?

  The device is explicitly labeled for single-use implantation within the cardiovascular system. It is supplied sterile and must be used once during surgery, after which it should not be reused. This aligns with standard sterile surgical protocols for implanted medical devices.

• What special handling or storage considerations apply to the CCS Model AV-102 before and after opening?

  The device is supplied sterile and must be handled according to sterile surgical protocols during and after opening. Since it is intended for implantation, it should be stored in its original packaging until ready for use, protected from contamination. Additionally, it is not MRI-safe, so patients with this device must avoid MRI procedures.

• How is the regulatory status of this device determined, and what classification does it fall under?

  The CCS Model AV-102 is classified as a Class III medical device under FDA regulations and has received 510(k) clearance. Its regulatory classification is based on its role as a permanent pacemaker electrode, which carries higher risk due to its implanted nature. The clearance was granted under the Cardiovascular (CV) advisory committee and is substantiated as *substantially equivalent* to a predicate device.