Lifeline Endocardial Bipolar Lead 484-03

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853519 ↗

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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  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

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  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 primary purpose of the Lifeline Endocardial Bipolar Lead 484-03, and how does it function within the body?

  The Lifeline Endocardial Bipolar Lead 484-03 is designed for endocardial placement inside the heart to provide bipolar pacing and sensing. This means it delivers electrical impulses to regulate heart rhythm and detects cardiac signals, supporting patients who require chronic pacing for conditions like bradycardia or heart block. The lead connects to compatible pacemaker systems to maintain stable cardiac function.

• Is this lead intended for single-use or reusable implantation, and how is it supplied?

  This lead is sterile and intended for single-use only after implantation. It is supplied pre-sterilized to ensure safety and reliability during surgical procedures, eliminating the need for reprocessing or reuse.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Lifeline Endocardial Bipolar Lead 484-03 was cleared through the traditional 510(k) review pathway by the FDA. It is classified as a Class III device, which requires premarket approval or 510(k) clearance due to its role in life-sustaining or life-supporting functions, such as cardiac rhythm management.

• Are there multiple models or sizes available for this lead, and how would a clinician determine the correct fit for a patient?

  The provided data does not specify variations in sizes or models for this particular lead (484-03). However, like most endocardial leads, selection typically depends on factors such as patient anatomy, pacing requirements, and compatibility with the implanted pacemaker system. Clinicians would consult manufacturer guidelines or product documentation for specific sizing recommendations based on the patient’s needs.