Model 437-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862258 ↗

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 437-01 Biopore Implantable Pacing Lead, and how does its design support that function?

  The Model 437-01 Biopore Implantable Pacing Lead is designed for transvenous implantation within the heart to deliver electrical stimulation, enabling cardiac pacing and rhythm management in patients with arrhythmias. Its Biopore surface promotes tissue integration, which helps reduce the risk of lead displacement over time, ensuring long-term stability and reliability during use with implantable cardiac pulse generators.

• Is the Model 437-01 Biopore Implantable Pacing Lead intended for reuse, or is it meant for single-use implantation?

  The Model 437-01 Biopore Implantable Pacing Lead is explicitly supplied sterile and intended for single-use implantation. This ensures patient safety and sterility during surgical procedures, as reuse is not recommended or supported by the manufacturer.

• What special handling or storage requirements apply to the Model 437-01 Biopore Implantable Pacing Lead before implantation?

  The lead must be handled in sterile conditions prior to surgical implantation, as it is supplied sterile. Beyond standard sterile packaging, no additional storage requirements are specified, meaning it should be stored according to general sterile medical device protocols until use.

• Can the Model 437-01 Biopore Implantable Pacing Lead be used in MRI procedures, or are there specific MRI-related considerations?

  The Model 437-01 Biopore Implantable Pacing Lead is MRI-unspecified, meaning its safety in MRI environments has not been explicitly defined. Clinicians should consult the manufacturer’s guidelines or relevant safety protocols before considering MRI use, as improper exposure could pose risks to the patient.

• What regulatory pathway was followed for the FDA clearance of the Model 437-01 Biopore Implantable Pacing Lead, and what does this imply for its use?

  The Model 437-01 Biopore Implantable Pacing Lead received FDA 510(k) clearance (K862258) under the Traditional review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This classification confirms it meets FDA standards for safety and effectiveness as a Class III Permanent Pacemaker Electrode, ensuring it adheres to strict regulatory requirements for cardiac pacing devices.