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510(k) Data Aggregation

    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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    K Number
    K003992
    Device Name
    PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
    Manufacturer
    PERCUSURGE, INC.
    Date Cleared
    2001-06-01

    (157 days)

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

    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 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.
    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
    K972777
    Device Name
    TEMPORARY OCCLUSION BALLOON SYSTEM
    Manufacturer
    PERCUSURGE, INC.
    Date Cleared
    1998-03-11

    (229 days)

    Product Code
    MJN, DAT
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PERCUSURGE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PercuSurge Temporary Occlusion Balloon (TOB) 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 (see WARNINGS).
    Device Description
    PercuSurge Temporary Occlusion Balloon (TOB) System
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