Lifeline Unipolar J-Lead #483-05

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K830463 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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• What is the primary clinical purpose of the Lifeline Unipolar J-Lead #483-05 and where is it implanted within the body?

  The Lifeline Unipolar J-Lead #483-05 is designed specifically for permanent implantation within the heart to deliver electrical pacing stimulation. It ensures proper cardiac rhythm by providing unipolar pacing, which is essential for patients requiring chronic cardiac rhythm management.

• Is this device intended for reuse or is it meant to be used only once after opening?

  This device is explicitly intended for single-use implantation only. It is supplied sterile and must not be reused after opening to maintain sterility and ensure patient safety.

• How should the Lifeline Unipolar J-Lead #483-05 be handled before implantation to ensure proper use?

  The lead must be handled using sterile procedures prior to implantation, as it is supplied in a sterile package. This ensures contamination is avoided and maintains its intended performance for delivering reliable cardiac pacing.

• What type of regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and efficacy?

  The Lifeline Unipolar J-Lead #483-05 received FDA 510(k) clearance through a traditional review pathway, meaning its safety and performance were evaluated by the FDA against legally marketed predicate devices. This process ensures it meets established standards for permanent pacemaker electrodes.

• Can this device be used in environments where MRI scans are performed, or are there specific restrictions?

  The device is labeled for use in MRI-unspecified settings, meaning its compatibility with MRI environments is not explicitly defined. Clinicians should follow strict protocols and consult manufacturer guidelines to avoid potential risks during MRI procedures, as pacemaker leads may interact with magnetic fields.