Polysafe Implant. Pacing Leads W/Trabeculok Tip

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

510(k) Number

K883015 ↗

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 Trabeculok tip on the Polysafe Implant Pacing Leads designed to improve, and how does it benefit patients?

  The Trabeculok tip is a specialized electrode design intended to enhance lead stability and integration within the heart’s trabecular network. This feature helps ensure more reliable electrical conduction for pacing therapies, which can improve long-term lead performance and reduce complications like dislodgment or poor signal transmission.

• Are these pacing leads meant for reuse, or are they single-use only? How should they be stored to maintain sterility?

  The Polysafe Implant Pacing Leads are intended for single-use only and are supplied sterile. To preserve sterility, they must be stored and handled according to standard sterile medical device protocols, typically in their original packaging until immediately before use.

• What sizes or models are available for the Polysafe Implant Pacing Leads, and how would I determine the right fit for a patient?

  The device data does not specify exact sizes or model variations, but these leads are designed as permanent pacemaker electrodes with a Trabeculok tip for cardiac pacing. Selection should be based on clinical assessment, including lead length, fixation requirements, and patient anatomy, ideally guided by the manufacturer’s sizing guidelines or a cardiologist’s recommendation.

• How should compatibility with MRI environments be addressed before using these leads in a patient?

  The device description explicitly states that MRI compatibility must be verified prior to use. This means clinicians should confirm with the manufacturer or consult MRI safety protocols to ensure the leads are safe for imaging in patients who may require MRI scans, as not all pacing leads are MRI-compatible.

• What regulatory pathway was followed for FDA clearance of these leads, and what does that mean for clinicians or buyers?

  The Polysafe Implant Pacing Leads were cleared via the FDA 510(k) pathway, specifically under a Traditional Review with a decision of *Substantially Equivalent* (SESE) to predicate devices. This means the FDA determined they meet the same performance standards as previously approved leads, ensuring they are safe and effective for their intended use as permanent pacemaker electrodes. Clinicians or buyers can rely on this clearance as evidence of regulatory scrutiny.