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510(k) Data Aggregation

    K Number
    K243998
    Device Name
    DCX Disposable Cassette (DCX)
    Manufacturer
    Institut Geroges Lopez
    Date Cleared
    2025-04-25

    (120 days)

    Product Code
    KDN
    Regulation Number
    876.5880
    Why did this record match?
    Applicant Name (Manufacturer) :

    Institut Geroges Lopez

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DCX Disposable Cassette, as part of the Kidney Perfusion System, is intended to be used for the pulsatile hypothermic machine perfusion (RM4 Kidney Perfusion System) of kidneys for preservation and eventual transplantation into a recipient only in healthcare professional environment.
    Device Description
    The DCX Disposable Cassette, provides a sterile fluid pathway, houses and protects the kidneys during perfusion and it has a gravity flow system which allows circulation of perfusate through the kidneys. The kidneys are placed in an organ chamber filled with perfusate. The perfusate flows from the organ chamber to the pumphead. Then, it is pumped through the heat exchanger to the bubble trap where it is delivered to the cannulated kidney(s). The perfusate then returns to the organ chamber via the kidney vein to repeat the perfusion cycle. The cassette can provide circulation of perfusate to one or two kidneys, attached individually or in bloc.
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