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    K Number
    K960422
    Device Name
    PRUITT SAFETY OCCLUSION CATHETER
    Manufacturer
    IDEAS FOR MEDICINE, INC.
    Date Cleared
    1996-08-07

    (191 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRUITT SAFETY OCCLUSION CATHETER

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

    The intended use of this device is for occlusion of the internal carotid artery during endarterectorny.

    Device Description

    The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. Every lot is supplied sterile and nonpyrogenic.

    AI/ML Overview

    I am sorry, but the provided text only contains a device description and regulatory classification information. It does not include any details about acceptance criteria, study methodologies, performance data, or ground truth establishment. Therefore, I cannot generate the requested information based on the input provided.

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