Model 486-02 Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860547 ↗

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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  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

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  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K844270 Active Cleared 28 Mar 1985

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  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 486-02 Endocardial Pacing Lead, and how does it function in the body?

  The Model 486-02 Endocardial Pacing Lead is designed to deliver electrical stimulation to the heart’s endocardial tissue, specifically the right atrium or ventricle. It transmits pacing impulses from an external pacemaker device to help regulate abnormal heart rhythms in patients who require chronic cardiac pacing support. This lead is implanted transvenously, meaning it is inserted through a vein and positioned inside the heart to ensure precise electrical conduction.

• Is the Model 486-02 Endocardial Pacing Lead intended for single-use or reusable applications, and what are the storage requirements?

  The Model 486-02 Endocardial Pacing Lead is supplied sterile and intended for single-use only. Due to its sterile packaging, storage must comply with standard sterile medical device protocols to maintain integrity until use. Improper storage could compromise sterility, so it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures.

• What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?

  The Model 486-02 Endocardial Pacing Lead received a Traditional 510(k) clearance (K860547) under the FDA’s substantial equivalence determination, meaning it was deemed comparable to a legally marketed predicate device. The review was conducted by the Cardiovascular (CV) Advisory Committee, which evaluates medical devices related to heart function and vascular health.

• How is this lead classified under FDA regulations, and what does that classification imply for its use?

  The Model 486-02 Endocardial Pacing Lead is classified as a Class III medical device (870.3680) under FDA regulations. This classification is reserved for devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury. As a Class III device, it requires pre-market approval (or in this case, a 510(k) clearance) to ensure safety and effectiveness before commercial distribution.