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510(k) Data Aggregation

    K Number
    K023351
    Device Name
    MAGIC INFUSION CATHETER
    Manufacturer
    ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC
    Date Cleared
    2003-02-20

    (136 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Magic Infusion Catheter is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The Magic Infusion Catheter may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
    Device Description
    The subject device is intended to operate for regional infusion of contrast materials into selected vessels in the neurovasculature. Magic Infusion Catheters are intended to facilitate access through distant, tortuous vasculature. Progressive suppleness ranging from a highly flexible tip to a semi-rigid proximal section allows the catheter to be advanced by the physician. It is not intended for use in the coronary vasculature. Magic catheters are available in 1.8 and 1.5Fr and 165 and 155 cm in length and are available with an "olive" tip configuration.
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