Polysafe CCS Trifix Endocardial Pacing Lead SV-107

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

510(k) Number

K853446 ↗

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 Polysafe CCS Trifix Endocardial Pacing Lead SV-107, and how does it function in the body?

  The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 is designed for endocardial pacing, meaning it delivers controlled electrical impulses directly to the inner lining of the heart. This helps regulate heart rate in patients with arrhythmias by ensuring proper cardiac function, effectively compensating for irregular electrical signals.

• Is this device intended for single-use or can it be reused after implantation?

  This device is not single-use—it is intended for permanent implantation in patients. As a reusable medical implant, it is meant to remain in place long-term to provide continuous pacing support. Sterility and handling instructions are provided by the manufacturer to ensure proper use during and after implantation.

• What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?

  The Polysafe CCS Trifix Endocardial Pacing Lead SV-107 followed the FDA 510(k) clearance pathway, specifically a Traditional review under product code DTB (Permanent Pacemaker Electrode). It was reviewed by the Cardiovascular (CV) Advisory Committee and classified as Class III under regulation 870.3680, with a decision date of January 13, 1986.

• Does this device comply with MRI safety standards, and if so, how does that affect its use?

  Yes, this device adheres to MRI safety standards for permanent pacemaker electrodes, meaning it is designed to be compatible with MRI procedures under specific conditions. However, the exact MRI safety parameters (e.g., field strength limits, imaging sequences) should be confirmed in the manufacturer’s documentation to ensure safe use in clinical settings.