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    K Number
    K013913
    Device Name
    PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
    Manufacturer
    MEDTRONIC PERCUSURGE, INC.
    Date Cleared
    2002-11-15

    (353 days)

    Product Code
    NFA
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC PERCUSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts (2.5-5.0mm) to: - Contain and aspirate embolic material (thrombus/debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures. - To subselectively infuse/deliver diagnostic or therapeutic agents with or without vessel occlusion. - The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature. - The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction. - The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.
    Device Description
    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System provides temporary vascular occlusion during diagnostic and interventional procedures in the coronary vasculature, specifically-diseased coronary bypass grafts. It is comprised of four principal components: the GuardWire Temporary Occlusion Catheter, the MicroSeal Adapter, the EZ Flator Inflation Device and the Export Aspiration Catheter. The GuardWire Plus System is a sterile, single-use disposable device.
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    K Number
    K014223
    Device Name
    MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM
    Manufacturer
    MEDTRONIC PERCUSURGE, INC.
    Date Cleared
    2002-01-25

    (30 days)

    Product Code
    NFA
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRONIC PERCUSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PercuSurge GuardWire Plus Temporary Occlusion & Aspiration System is indicated for use in the coronary saphenous vein bypass grafts to: - Contain and aspirate embolic material (thrombus/debris) while performing . Somain and aspenary angioplasty or stenting procedures. - To subselectively infuse/deliver diagnostic or therapeutic agents with or . without vessel occlusion. - · The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.
    Device Description
    Not Found
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