Model 492-02 Endocardial Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K860548 ↗

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

• Implant Aid Splicing Crimp & Sleeve

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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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  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 492-02 Endocardial Pacing Lead, and where is it typically implanted within the body?

  The Model 492-02 Endocardial Pacing Lead is designed to deliver electrical impulses for endocardial stimulation, helping regulate cardiac rhythm in patients who require permanent pacing support. It is specifically intended for implantation within the right ventricle or atrium of the heart to ensure precise pacing and synchronization of heart contractions, particularly for conditions like bradycardia or conduction disorders.

• Is the Model 492-02 Endocardial Pacing Lead meant for single-use or reusable applications, and how should it be stored to maintain sterility?

  The Model 492-02 Endocardial Pacing Lead is supplied sterile and intended for single-use implantation only. To maintain sterility and functionality, it must be handled under aseptic conditions before use and stored according to the manufacturer’s guidelines, which are detailed in the accompanying documentation.

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

  The Model 492-02 Endocardial Pacing Lead received FDA 510K clearance through a traditional review pathway, determined to be substantially equivalent to predicate devices. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations.

• Can this lead be used with standard pacemaker systems, and what precautions should be taken during handling?

  Yes, the Model 492-02 Endocardial Pacing Lead is compatible with standard pacemaker systems. However, it must be handled under aseptic conditions prior to implantation, as it is a sterile, single-use device. Adherence to manufacturer storage instructions is critical to preserve its sterility and functionality.