CCS Model AV-106 Implantable A-V Data Lead

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K851897 ↗

FDA Product Code

DTD

Device Class

Class II

Regulation

21 CFR Part 870.3620

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 CCS Model AV-106 Implantable A-V Data Lead used for?

  The CCS Model AV-106 Implantable A-V Data Lead is designed to facilitate atrial-ventricular data transmission in cardiac pacing systems, serving as a pacemaker lead adaptor for cardiovascular applications requiring implantable device integration.

• Is the CCS Model AV-106 Implantable A-V Data Lead sterile and single-use?

  Yes, the device is supplied as a sterile, single-use implantable lead, intended for one-time use in clinical settings during cardiovascular device implantation procedures to maintain sterility and prevent cross-contamination.

• What regulatory pathway was used for the CCS Model AV-106 Implantable A-V Data Lead?

  The device received FDA 510(k) clearance under submission K851897 on August 9, 1985, based on a determination of substantial equivalence to a predicate device, which is the standard regulatory route for moderate-risk class II medical devices.

• Who manufactures the CCS Model AV-106 Implantable A-V Data Lead and where is it produced?

  The device is manufactured by Cardiac Control Systems, Inc., located at 3 Commerce Blvd., Palm Coast, FL 32164, United States, as indicated in the manufacturer’s registration and facility details.