Polysafe Endocardial Pacing Lead

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

Full name

Ccs Polysafe(Tm) Endocardial Pacing Lead

510(k) Number

K864601 ↗

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 Polysafe™ Endocardial Pacing Lead, and how is it implanted in patients?

  The CCS Polysafe™ Endocardial Pacing Lead is designed for endocardial pacing, delivering electrical stimulation directly to the heart’s inner lining (endocardium) to regulate cardiac rhythm in patients requiring chronic pacing support. It is typically implanted via venous access, positioning the electrode tip within the right ventricle or atrium to ensure reliable pacing over long-term use.

• Is the CCS Polysafe™ Endocardial Pacing Lead intended for single-use or reusable applications, and how should it be stored?

  The lead is sterile and intended for single-use only, as specified in its design. Storage must follow the manufacturer’s guidelines to maintain sterile packaging integrity, ensuring it remains uncontaminated until use.

• Does this device comply with MRI safety standards, and if so, what class does it fall under?

  Yes, the CCS Polysafe™ Endocardial Pacing Lead is designed to comply with MRI safety standards and is classified as a Class C device, allowing for controlled MRI imaging under specific conditions.

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

  The device underwent a Traditional 510(k) review and was deemed Substantially Equivalent (SESE) to a predicate. It was reviewed by the Cardiovascular (CV) Advisory Committee and cleared under FDA 510(k) number K864601, governed by regulation 870.3680.