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510(k) Data Aggregation

    K Number
    K955534
    Device Name
    SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)
    Manufacturer
    INTERNATIONAL INNOVATIONS, INC.
    Date Cleared
    1996-08-01

    (241 days)

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

    INTERNATIONAL INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Segue ™ Infusion Catheter is indicated for the delivery of therapeutic agents into the peripheral vasculature. It is not indicated for use in coronary or cerebral vasculature. It is not intended for use with thrombolytics. It is not intended for use with power injection pumps.
    Device Description
    The Segue ™ Infusion Catheter is a single lumen, over-the-wire device designed to locally deliver fluids into the peripheral (non-coronary, non-cerebral) vasculature
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