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510(k) Data Aggregation

    K Number
    K140557
    Device Name
    MIVI 6F GUIDE CATHETER
    Manufacturer
    MIVI, LLC
    Date Cleared
    2014-09-18

    (197 days)

    Product Code
    DQY
    Regulation Number
    870.1250
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    Applicant Name (Manufacturer) :

    MIVI, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
    Device Description
    The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.
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