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510(k) Data Aggregation

    K Number
    K960937
    Device Name
    SUCTION SAFETY DEVICE
    Manufacturer
    R D INTL.
    Date Cleared
    1996-06-05

    (89 days)

    Product Code
    MJJ
    Regulation Number
    870.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    R D INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI Suction Safety Device is intended to be used during open heart surgery and placed in a suction line to permit flow only away from the heart, prevent buildup of line pressure, and limit line vacuum.
    Device Description
    The RDI Suction Safety Device is a three function assembly that is positioned in a suction line. The Suction Safety Device contains to valves. The first valve is a check valve that insures unidirectional flow. The second valve is a combination valve that relieves excess pressure and relieves excess vacuum.
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    K Number
    K960312
    Device Name
    RDI CARDIAC INSULATION PAD
    Manufacturer
    R D INTL.
    Date Cleared
    1996-04-19

    (88 days)

    Product Code
    DWP
    Regulation Number
    870.4475
    Why did this record match?
    Applicant Name (Manufacturer) :

    R D INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RDI Cardiac Insulation Pad is intended to be used during open heart surgery to insulate the myocardium from the warmer organs and tissues in the body and thus reduce undesired rewarming of the heart.
    Device Description
    The RDI Cardiac Insulation Pad consists of a pear shaped, 1/8" thick, closed cell polyethylene foam material. Attached to the foam is a 1/2" wide, 20" long, 4 mil thick, polyvinyl chloride strip referred to as a "tail".
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