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510(k) Data Aggregation

    K Number
    K991007
    Device Name
    K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60
    Manufacturer
    KATECHO, INC.
    Date Cleared
    1999-08-23

    (150 days)

    Product Code
    MKJ,MLN
    Regulation Number
    870.5310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    K-DEFIB/PACE RADIOLUCENT ADULT ELECTRODE, MODEL KRT-60

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Katecho External Radiolucent electrode is indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device, for single patient use, only. The KRT-60 Radiolucent electrode provides the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the patients skin. The electrode is intended for use on adult patients.

    When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the patient and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum).

    This device has been tested to the ANSI/AAMI DF2-1996 standard for use with equipment: Laerdal, Heartstream, Marquette, Physio Control, Survivalink, First Medic, and Hewlett-Packard.

    Device Description

    K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60

    AI/ML Overview

    This letter is a 510(k) premarket notification for the K-Defib/Pace Radio Lucent Adult Electrode Model KRT-60. It states that the device is substantially equivalent to legally marketed predicate devices. The document does not contain information about the acceptance criteria and the study proving the device meets said criteria. Therefore, I cannot answer the request.

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