Model 431-02 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862257 ↗

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

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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 Model 431-02 Biopore Implantable Pacing Lead, and how does the Biopore coating benefit patients?

  The Model 431-02 Biopore Implantable Pacing Lead is designed for transvenous implantation to deliver electrical pacing impulses to the heart, specifically targeting the right ventricle or atrium. This helps regulate cardiac rhythm in patients with bradycardia or conduction disorders. The Biopore coating promotes better tissue integration and reduces fibrosis, which improves long-term stability and performance of the lead by minimizing complications like lead displacement or failure over time.

• Is this device intended for reuse, or is it meant to be used only once? How should it be handled to maintain sterility?

  The Model 431-02 Biopore Implantable Pacing Lead is supplied sterile and intended for single-use implantation only. To maintain sterility, it must be handled in a controlled clinical environment, such as a cardiac catheterization lab or operating room, and protected from moisture and extreme temperatures as specified in the storage instructions. Single-use ensures patient safety and reduces the risk of infection or contamination.

• What precautions should clinicians take when using this lead in a magnetic resonance (MRI) environment?

  The Model 431-02 Biopore Implantable Pacing Lead is labeled as MRI-unspecified, meaning its safety in MRI environments has not been fully established. Clinicians must exercise extreme caution when considering MRI procedures for patients with this lead implanted. Consultation with a cardiologist or MRI facility is strongly advised to assess potential risks, as improper use could lead to device malfunction or patient harm.

• How is this device classified under FDA regulations, and what does that mean for its use in clinical settings?

  The Model 431-02 Biopore Implantable Pacing Lead is classified as a Class III device under FDA regulations (870.3680), which means it is subject to stringent premarket approval requirements due to its high-risk nature. This classification ensures that the device undergoes rigorous evaluation for safety and effectiveness before use. Clinicians must follow FDA guidelines and manufacturer instructions to ensure proper implantation, positioning, and connection to a pacemaker pulse generator, as it requires professional handling.

• What types of clinical settings are appropriate for implantation of this pacing lead, and why?

  This lead is intended for implantation in clinical settings such as cardiac catheterization labs or operating rooms, where qualified healthcare professionals can ensure sterile conditions and precise placement. These environments provide the necessary infrastructure, expertise, and monitoring capabilities to safely perform transvenous lead implantation, reduce infection risks, and confirm proper function before connecting it to a pacemaker pulse generator.