Lifeline Pacing Lead Model 465-01

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781497 ↗

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 primary purpose of the Lifeline Pacing Lead Model 465-01 in clinical practice?

  The Lifeline Pacing Lead Model 465-01 is designed to deliver electrical impulses to the heart to regulate abnormal heart rhythms, specifically for patients with bradycardia or conduction disorders. It connects to a pacemaker to provide precise and reliable pacing support, ensuring consistent cardiac contraction when the heart’s natural rhythm is compromised.

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

  The Lifeline Pacing Lead Model 465-01 is supplied sterile and explicitly intended for single-use implantation in a clinical setting. It is not designed for reuse, as its sterile packaging and one-time-use labeling reflect standard practices for implanted cardiovascular devices to ensure patient safety and sterility.

• How should the device be stored to maintain its sterility and functionality before use?

  Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, it should remain in its original, unopened packaging until immediately before implantation. Exposure to moisture, extreme temperatures, or contamination could compromise its integrity, so adherence to Intermedics’ specific storage instructions is critical.

• Can this pacing lead be used in patients who require MRI scans, and if so, under what conditions?

  Yes, the Lifeline Pacing Lead Model 465-01 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 avoid risks like lead displacement or interference. Always refer to the device’s labeling or consult Intermedics’ instructions for MRI-compatible use.

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

  The Lifeline Pacing Lead Model 465-01 received FDA 510(k) clearance under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards. The clearance was granted in 1979, though subsequent manufacturing updates may apply.