BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    MEDIASTINAL AUTOTRANSFUSION SYSTEM

    K Number: K860775 · Decision May 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    23
    Review Days
    86

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    Basic Information

    Device Name
    MEDIASTINAL AUTOTRANSFUSION SYSTEM
    K Number
    K860775
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardio Metrics, Inc.
    Date Received
    March 3, 1986
    Decision Date
    May 28, 1986
    Product Code
    DTP
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DTP Defoamer, Cardiopulmonary Bypass

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    Other Clearances by Cardio Metrics, Inc.

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    K961777 ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
    K955551 CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
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    K952562 CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE
    K943022 CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE
    K940984 CARDIOMETRICS DUALFLOW SWITCH BOX
    K933320 CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT
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