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510(k) Data Aggregation

    K Number
    K053169
    Device Name
    RM3 RENAL PRESERVATION SYSTEM
    Manufacturer
    WATERS INSTRUMENTS, INC.
    Date Cleared
    2006-01-17

    (64 days)

    Product Code
    KDK
    Regulation Number
    876.5880
    Why did this record match?
    Product Code :

    KDK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RM3 Renal Preservation System is intended to be used to maintain kidneys for transplant.
    Device Description
    The RM3 Renal Preservation System is a lightweight, transportable and self-contained renal preservation system, designed to support static monitoring and transportation of kidneys. The RM3 system provides controlled kidney perfusion of hypothermic physiologic solutions, and monitors, displays, trends, and saves important perfusion parameters, including: perfusate flow, temperature, pressure, and renal resistance. The RM3 system control unit can be configured to signal an audio and visual alarm for user-selected limits, and print user-selected data and waveforms. The RM3 Renal Preservation System is a two-part system comprising a control unit for perfusion and monitoring of one or two kidneys, and a sterile, disposable single-use cassette used to contain and circulate perfusate to the kidneys.
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