Model 431-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K854918 ↗

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 Model 431-01 Biopore Implantable Pacing Lead, and how is it implanted?

  The Model 431-01 Biopore Implantable Pacing Lead is designed to deliver electrical stimulation to the heart for patients with bradycardia or conduction disorders, providing consistent pacing support. It is implanted transvenously, meaning it is inserted through a vein and positioned in the right atrium or ventricle for chronic cardiac pacing.

• Is the Model 431-01 Biopore Implantable Pacing Lead intended for reuse, or is it meant to be used only once?

  The Model 431-01 Biopore Implantable Pacing Lead is explicitly intended for single-use implantation. It is supplied sterile and packaged for surgical use, ensuring it remains uncontaminated for one-time patient use.

• What regulatory pathway was followed for FDA clearance of this device, and which committee reviewed it?

  The Model 431-01 Biopore Implantable Pacing Lead received FDA 510(k) clearance under the Cardiovascular (CV) Advisory Committee, following a traditional review process. The decision was classified as *Substantially Equivalent* (SESE), confirming compliance with Class III regulatory standards for permanent pacemaker electrodes.

• How should the Model 431-01 Biopore Implantable Pacing Lead be stored before use, and what precautions should be taken?

  The lead is supplied sterile and packaged for surgical use, so it must be stored in its original, unopened packaging to maintain sterility. Avoid exposure to moisture, extreme temperatures, or contamination until immediate preoperative use. Follow manufacturer guidelines for shelf-life and handling to ensure device integrity.