Lifeline Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K792168 ↗

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

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  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

See all devices from Intermedics, Inc. →

• What is the Lifeline Endocardial Pacing Lead primarily used for in clinical practice?

  The Lifeline Endocardial Pacing Lead is designed to deliver electrical stimulation directly to the heart muscle as part of a cardiac pacing system. It is intended for patients with bradycardia (slow heart rate) or conduction disorders, helping to regulate their heart rhythm by ensuring consistent electrical impulses.

• Is the Lifeline Endocardial Pacing Lead intended for reuse, or is it meant to be implanted once and discarded?

  The device is supplied sterile and explicitly intended for single-use implantation within the endocardium. Once implanted, it is not designed for removal or reuse, adhering to standard sterile surgical practices for permanent pacemaker electrodes.

• How is the Lifeline Endocardial Pacing Lead packaged for surgical use, and what does that imply for handling?

  The lead is distributed in sterile packaging, ensuring it remains uncontaminated until ready for implantation. This packaging is designed for surgical environments, meaning it must be opened aseptically under sterile conditions to maintain sterility before use.

• Can this device be used in patients who require MRI scans, and what considerations should be made?

  Yes, the Lifeline Endocardial Pacing Lead is compatible with MRI environments according to the manufacturer’s specifications. However, MRI use must follow strict protocols to avoid interference or complications, such as adhering to MRI-safe positioning and field strength guidelines to ensure patient safety.

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

  The Lifeline Endocardial Pacing Lead underwent a Traditional 510(k) review through the FDA’s Cardiovascular (CV) advisory committee, with a decision of Substantially Equivalent (SE) to a predicate device. It is classified as a Class III medical device (870.3680), reflecting its role in life-sustaining or supporting functions, which requires rigorous pre-market clearance.