Model 436-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862051 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the primary clinical purpose of the Model 436-01 Biopore Implantable Pacing Lead, and how is it implanted?

  The Model 436-01 Biopore Implantable Pacing Lead is designed to deliver electrical pacing stimuli to the heart for patients with bradycardia or conduction disorders. It is implanted transvenously, meaning it is inserted through a vein (typically the subclavian or jugular vein) and advanced into the heart chamber where pacing is required. This procedure is performed by trained healthcare professionals in a clinical setting.

• Is the Model 436-01 Biopore Implantable Pacing Lead intended for reuse, or is it single-use only?

  The Model 436-01 Biopore Implantable Pacing Lead is explicitly intended for single-use implantation only. It is supplied sterile and should not be reused after initial use to ensure patient safety and device efficacy.

• How should the Model 436-01 Biopore Implantable Pacing Lead be stored, and what precautions should be taken?

  The lead must be stored according to the manufacturer’s guidelines to maintain sterile packaging integrity. This includes keeping it in its original, unopened packaging, protecting it from physical damage, and ensuring it remains in a clean, dry environment. Avoid exposure to extreme temperatures or moisture, as these could compromise sterility or device performance.

• Can this device be used in patients who require MRI scans, and if so, what conditions apply?

  The Model 436-01 Biopore Implantable Pacing Lead is compatible with MRI environments under specific conditions, as outlined in its labeling. However, strict adherence to MRI safety parameters is required to prevent adverse events. Clinicians must follow the manufacturer’s guidelines and consult the device’s labeling for detailed MRI safety instructions before proceeding.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Model 436-01 Biopore Implantable Pacing Lead was cleared through the FDA 510(k) pathway under the traditional review process, with a decision of *Substantially Equivalent* (SESE). It is classified as a Class III medical device under product code DTB, reflecting its role as a permanent pacemaker electrode for critical cardiac rhythm regulation. The clearance number is K862051.