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510(k) Data Aggregation

    K Number
    K190369
    Device Name
    M-Y Sheath
    Date Cleared
    2019-04-17

    (61 days)

    Product Code
    Regulation Number
    870.1340
    Why did this record match?
    Applicant Name (Manufacturer) :

    RAM Medical Innovations, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The M-Y Sheath is intended to enable delivery of interventional and diagnostic devices into the human vasculature, excluding coronary and neuro vasculature.
    Device Description
    The M-Y Sheath is a contralateral access guiding sheath with a proximal hemostatic valve and an integrated fixed wire at its distal end. The fixed wire is attached to the sidewall of the sheath and extends beyond the distal tip of the sheath and is used to provide sheath support during use. The wire distal end is first introduced through the ipsilateral in-dwelling femoral sheath introducer. then snared and externalized through an in-dwelling contralateral sheath introducer, thereby allowing the sheath to be positioned over the bifurcation by gentle simultaneous pushing and pulling the device using a "flossing" technique. Once the M-Y sheath tip is positioned at the desired location in the contralateral vasculature. the wire can be externally secured (e.g. using a pin vise), thereby providing stability and support when advancing interventional tools (e.g. angioplasty balloons, stents, etc.). The M-Y Sheath is compatible to fit through a standard 7 French femoral sheath introducer placed in the ipsilateral leg. The M-Y Sheath luminal diameter is sized to be compatible with 5 French therapeutic and diagnostic devices.
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