Model 492-01 Pacemaker Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813136 ↗

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) K813518 Active Cleared 12 Jan 1982

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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Model 492-01 Pacemaker Lead, and where is it typically implanted in the body?

  The Model 492-01 Pacemaker Lead is designed to deliver timed electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders. It is intended for implantation within the cardiovascular system, specifically positioned in the right atrium or ventricle to ensure proper pacing signals and maintain consistent heart function.

• Is the Model 492-01 Pacemaker Lead reusable, or is it meant for single-use only?

  The Model 492-01 Pacemaker Lead is supplied sterile and explicitly intended for single-use. It requires surgical placement by a healthcare professional, and reuse is not recommended or supported by the manufacturer.

• How is the regulatory status of this device determined, and what classification does it hold?

  The Model 492-01 Pacemaker Lead holds a Class III regulatory classification under FDA regulation number 870.3680, meaning it is subject to strict controls due to its role in sustaining or supporting life. It was granted FDA 510(k) clearance through the traditional review pathway, with a decision of Substantially Equivalent to a predicate device, as reviewed by the Cardiovascular (CV) Advisory Committee.

• What type of review pathway was used for FDA clearance of this pacemaker lead, and how long did the process take?

  The Model 492-01 Pacemaker Lead underwent the traditional 510(k) review pathway, which involves a detailed evaluation by the FDA to determine substantial equivalence to a legally marketed predicate device. The application was initially received on November 5, 1981, and clearance was granted on April 3, 1985, reflecting a thorough review process.