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510(k) Data Aggregation

    K Number
    K113235
    Device Name
    PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS
    Manufacturer
    MEDTRONIC INC.
    Date Cleared
    2011-12-02

    (30 days)

    Product Code
    DXS, CLA
    Regulation Number
    870.4310
    Why did this record match?
    Product Code :

    DXS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pressure Display Box: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery. DLP® Disposable Pressure Display Set: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products.
    Device Description
    Not Found
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