Lifeline Pacing Lead Model 467-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781499 ↗

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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  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  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) 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 clinical purpose of the Lifeline Pacing Lead Model 467-01, and how does it function in the body?

  The Lifeline Pacing Lead Model 467-01 is designed to deliver electrical stimulation to the heart for patients with bradycardia or other cardiac rhythm disorders. It is implanted within the cardiac chambers to regulate heart rate and maintain proper cardiac function, providing long-term pacing support for patients who require it.

• Is this device intended for single-use or reusable applications, and how should it be handled to maintain sterility?

  This device is supplied sterile and intended for single-use implantation only. To maintain sterility, it must be stored according to the manufacturer’s instructions, typically in its original packaging until ready for use in a clinical setting.

• Can this pacing lead be used in patients who require MRI scans, and if so, are there specific conditions or restrictions?

  Yes, the Lifeline Pacing Lead Model 467-01 is compatible with MRI environments under specific conditions, as outlined in its labeling. However, the exact parameters (e.g., MRI strength, safety protocols) must be followed to ensure patient safety during imaging.

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

  The Lifeline Pacing Lead Model 467-01 received FDA 510(k) clearance under the Traditional review pathway, determined to be substantially equivalent to predicate devices. It is classified as a Class III medical device under FDA regulations (870.3680), reflecting its role in life-sustaining or life-supporting functions.