Polysafe Implant. Pacing Leads W/Tined Fixa. Tip

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

510(k) Number

K883016 ↗

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. →

• Are these pacing leads designed for reuse, or are they intended for single-use only?

  The Polysafe Implant Pacing Leads with Tined Fixation Tip are supplied sterile and explicitly intended for single-use only. This is standard practice for implanted medical devices to ensure patient safety and prevent infection risks associated with reuse.

• What types of pacemaker systems are these leads compatible with, and how do I identify the correct model for my patient?

  These leads are designed for compatibility with various pacemaker systems and come in multiple model references, including 3002618605, 3008377825, and others. The manufacturer’s documentation or your pacemaker’s specifications should guide model selection to ensure proper fit and function.

• How should these leads be stored to maintain sterility before use?

  Since these leads are sterile upon packaging, they must be stored according to sterile medical device protocols—typically in a clean, dry environment, away from direct sunlight or extreme temperatures, and protected from contamination until implantation.

• What is the regulatory pathway for these pacing leads, and how does it affect their use?

  The Polysafe Implant Pacing Leads received FDA 510(k) clearance (K883016) under the product code DTB, confirming they meet U.S. regulatory standards for permanent pacemaker electrodes. This clearance ensures they comply with safety and performance requirements for cardiovascular devices, but it does not dictate clinical indications—those are determined by physician assessment.