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    K Number
    K955717
    Device Name
    ENDOSCOPE INTRODUCER KIT
    Manufacturer
    MITSUBISHI CABLE AMERICA, INC.
    Date Cleared
    1996-04-18

    (122 days)

    Product Code
    FDE
    Regulation Number
    876.1500
    Why did this record match?
    Product Code :

    FDE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mitsubishi Endoscope Introducer Kit is intended to provide an open channel to allow insertion of a small diameter endoscope during laparoscopic choledochoscopy.
    Device Description
    The Mitsubishi Endoscope Introducer Kit consists of an internal dilator (with luer fitting to accommodate a hemostasis valve) contained within an external sheath (with attached hemostasis valve and luer fitting). The dilator may be straight or curved and has a lumen to allow passage of a flexible guidewire.
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