Model 486-05 Polyflex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

Full name

Model 486-05 Polyflex(R) Implantable Pacing Lead

510(k) Number

K864564 ↗

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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  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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• 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. →

• Is the Model 486-05 Polyflex Implantable Pacing Lead reusable or intended for single-use only?

  The Model 486-05 Polyflex Implantable Pacing Lead is explicitly designed for single-use implantation within the cardiovascular system. It is supplied sterile via ethylene oxide sterilization and is not intended for reuse after implantation.

• What types of heart conditions is this pacing lead intended to address?

  This lead is intended for cardiac pacing applications, specifically to regulate heart rhythm in patients with bradycardia or conduction disorders. It delivers electrical impulses to ensure consistent atrial or ventricular stimulation via an implanted lead system.

• How is this device sterilized, and what precautions should be taken during handling?

  The Model 486-05 Polyflex Implantable Pacing Lead is sterilized using ethylene oxide, ensuring it is supplied in a sterile condition. Since it is intended for surgical implantation, it must be handled under aseptic conditions by qualified healthcare professionals to maintain sterility until use.

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

  The lead is compatible with MRI environments under specific conditions, as outlined in its labeling. However, the exact parameters (e.g., MRI strength, safety protocols) are not detailed in the provided data, so clinicians should refer to the device’s official labeling or manufacturer instructions for precise MRI compatibility guidelines.

• What regulatory pathway was followed for this device’s approval, and what classification does it hold?

  The Model 486-05 Polyflex Implantable Pacing Lead was cleared through the FDA’s 510(k) Traditional pathway and is classified as a Class III device under FDA regulations. It was determined to be substantially equivalent to a predicate device, with the clearance filed in 1986 under the Cardiovascular (CV) Advisory Committee.