Model 486-01 Pacemaker Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813135 ↗

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 486-01 Pacemaker Lead, and how does it function in the body?

  The Model 486-01 Pacemaker Lead is designed to deliver electrical impulses directly to the heart to treat bradycardia or other cardiac rhythm disorders. It functions by being implanted within the cardiac chambers, where it stimulates contractions to maintain proper heart function in patients requiring chronic pacing support. This ensures consistent, regulated heartbeats when the natural pacemaker fails.

• Is the Model 486-01 Pacemaker Lead intended for reuse, or is it meant to be used only once?

  The Model 486-01 Pacemaker Lead is explicitly intended for single-use implantation in a clinical setting. It is supplied sterile and must be handled under aseptic conditions prior to use, as it is not designed for reuse after implantation. This aligns with its classification as a disposable medical implant under FDA standards.

• How should the Model 486-01 Pacemaker Lead be stored before use, and what precautions should be taken?

  The lead is supplied sterile, so storage must maintain its integrity until use. It should be kept in its original packaging, protected from contamination, moisture, and physical damage. Since it is intended for single-use implantation, it must be handled under aseptic conditions in a clinical setting to prevent infection or compromise of sterility before insertion.

• What regulatory pathway was followed for FDA clearance of the Model 486-01 Pacemaker Lead, and what does this mean for its use?

  The Model 486-01 Pacemaker Lead received FDA 510(k) clearance (K813135) under the Traditional review pathway, with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means the FDA determined it is as safe and effective as a previously approved device and is classified under Class III regulatory standards, reflecting its role in life-sustaining or supporting functions. The clearance is tied to its use as a *Permanent Pacemaker Electrode* for cardiac rhythm management.