Lifeline Endocardial Unipolar 487-06 TLE Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853520 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

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  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

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• What is the primary purpose of the Lifeline Endocardial Unipolar 487-06 TLE Lead in a clinical setting?

  The Lifeline Endocardial Unipolar 487-06 TLE Lead is designed specifically for endocardial placement within a pacemaker system. It delivers unipolar pacing stimulation to the heart’s inner lining (endocardium) to help regulate cardiac rhythm in patients who require pacing support, such as those with bradycardia or conduction system disorders.

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

  This lead is supplied sterile and is intended for single-use only. It must remain unopened and sterile until immediately before implantation to ensure patient safety and proper functionality.

• How is the lead classified under FDA regulations, and what does that mean for its use?

  The Lifeline Endocardial Unipolar 487-06 TLE Lead is classified as a Class III device under FDA regulation number 870.3680, meaning it is subject to strict premarket approval requirements due to its role in life-sustaining or life-supporting functions. It was cleared via the traditional 510(k) pathway and is determined to be substantially equivalent to a predicate device, ensuring it meets established safety and effectiveness standards for cardiovascular applications.

• What handling precautions should be taken before and during implantation?

  The lead must be handled under sterile conditions prior to implantation, as it is supplied sterile and intended for single-use. Any breach of sterility—such as opening the packaging before use or improper storage—could compromise its integrity and increase infection risks for the patient.

• Is this lead compatible with all pacemaker systems, or are there specific system requirements?

  While the Lifeline Endocardial Unipolar 487-06 TLE Lead is designed for use within a pacemaker system, compatibility depends on the specific pacemaker model and manufacturer’s guidelines. Clinicians should verify compatibility with their chosen pacemaker system before implantation, as not all systems may support unipolar endocardial leads.