Model 432-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862053 ↗

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 432-01 Biopore Implantable Pacing Lead, and how does its design improve patient outcomes?

  The Model 432-01 Biopore Implantable Pacing Lead is designed to deliver controlled electrical impulses to regulate cardiac rhythm in patients requiring pacing support. Its biopore design promotes better tissue integration and stability within the heart, which helps reduce complications and improves long-term performance compared to standard leads.

• Is the Model 432-01 Biopore Implantable Pacing Lead intended for reuse, or is it meant for single-use implantation?

  The device is explicitly supplied sterile and intended for single-use implantation only. It must be used once and discarded, ensuring patient safety and sterility in clinical settings like cardiac catheterization labs or operating rooms.

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

  The Model 432-01 received FDA clearance under a 510(k) submission (K862053), classified as Substantially Equivalent (SESE) to predicate devices. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared lead, ensuring it meets regulatory standards for safety and effectiveness.

• Where and how should this device be stored, and are there any special handling instructions provided?

  The available data does not specify storage conditions for the Model 432-01 Biopore Implantable Pacing Lead. However, as a sterile, single-use device, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use, following standard medical device storage protocols.

• Does this device have any known limitations regarding MRI compatibility, and what should clinicians consider before use?

  The data does not provide specific MRI safety information for the Model 432-01 Biopore Implantable Pacing Lead. Clinicians should exercise caution when considering MRI procedures for patients with this device, as implantable leads may pose risks in magnetic fields. Consulting the manufacturer’s latest guidelines or safety data is strongly advised.