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    K Number
    K081454
    Device Name
    GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
    Manufacturer
    POSSIS MEDICAL, INC.
    Date Cleared
    2008-06-13

    (21 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K062220
    Why did this record match?
    Device Name :

    GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE

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

    The GuardDOG® Occlusion System is indicated for use in the peripheral vasculature to facilitate the localized infusion of therapeutic or diagnostic fluids, with or without vessel occlusion.

    The safety and effectiveness of this device have not been established in the coronary, cerebral, or carotid vasculature.

    Device Description

    The GuardDOG System consists of two components: An Occlusion Guidewire and a carbon dioxide (CO2) Inflation Device. The GuardDOG Inflation Device is used to inflate the occlusion balloon and seal the guidewire once it is in position.

    AI/ML Overview

    I am sorry, but the provided text only refers to mechanical, biocompatibility, sterility, and animal testing without going into the specifics of the acceptance criteria or how the device performance was measured against them. Consequently, I cannot provide an answer following the requested template as it would require information not present in the given document.

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