Polysafe Implantable Pacing Lead

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

Full name

Polysafe(Tm) Implantable Pacing Lead

510(k) Number

K884024 ↗

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 types of patients is the Polysafe Implantable Pacing Lead designed to support, and how is it implanted?

  The Polysafe Implantable Pacing Lead is designed for patients with bradycardia or conduction disorders requiring consistent cardiac pacing. It is implanted either subcutaneously or intravascularly to deliver electrical stimulation and regulate heart rhythm. The lead is intended for single-use implantation within the cardiovascular system, ensuring reliable pacing support.

• How is the Polysafe Implantable Pacing Lead supplied, and is it sterile?

  The Polysafe Implantable Pacing Lead is supplied sterile and packaged specifically for surgical use. This ensures it is ready for direct implantation without additional sterilization steps, meeting clinical standards for cleanliness and safety.

• Can this device be reused, and what are the implications for its use?

  The Polysafe Implantable Pacing Lead is explicitly designed for single-use implantation. Reuse is not recommended or supported, as it could compromise sterility, functionality, or patient safety. Each lead is intended for one-time use in a patient’s cardiovascular system.

• What regulatory pathway does the Polysafe Implantable Pacing Lead follow, and how does this affect its use?

  The Polysafe Implantable Pacing Lead follows the FDA 510(k) clearance pathway (K884024) and is classified as a Class III medical device under 21 CFR 870.3680. This classification reflects its critical role in cardiac pacing, ensuring rigorous oversight for safety and efficacy. The clearance indicates it is deemed substantially equivalent to a predicate device, but clinicians should always refer to the latest FDA guidance or manufacturer instructions for specific use.

• Is the Polysafe Implantable Pacing Lead compatible with MRI environments, and if so, under what conditions?

  Yes, the Polysafe Implantable Pacing Lead is designed to be compatible with MRI environments under specified conditions. However, the exact parameters (e.g., MRI strength, patient positioning, or imaging protocols) are not detailed in the provided data. Clinicians should consult the manufacturer’s instructions or MRI safety guidelines to ensure proper use and avoid risks like lead displacement or interference.