Lifeline TLE J-Shaped Atrial Endocardial Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Lifeline Tle J-Shaped Atrial Endocardial

510(k) Number

K792301 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Lifeline TLE J-Shaped Atrial Endocardial Electrode, and how does it function in the body?

  The Lifeline TLE J-Shaped Atrial Endocardial Electrode is designed for endocardial placement within the atrium of the heart. It delivers electrical stimulation to regulate cardiac rhythm in patients with bradycardia or atrial conduction disorders, ensuring proper pacing and synchronization of heart contractions. By providing timed electrical impulses, it helps maintain a consistent and effective heartbeat.

• Is this device intended for reuse, or is it meant to be used only once during implantation?

  This device is explicitly intended for single-use implantation. It is supplied sterile and packaged for direct surgical use, ensuring safety and reliability for one-time use in cardiovascular procedures.

• What special considerations should be taken into account when storing this device before use?

  The device is supplied in sterile packaging, which should be preserved until immediate use. Since it is intended for single-use, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain sterility and integrity until implantation.

• Does this device have any compatibility with MRI environments, and if so, under what conditions?

  Yes, the Lifeline TLE J-Shaped Atrial Endocardial Electrode is compatible with MRI environments, but only under specified conditions. These conditions are likely outlined in the manufacturer’s instructions for use, so clinicians should refer to those guidelines to ensure safe and effective imaging.