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

    MODIFIED SARNS MEMBRANE OXYGENATOR

    K Number: K863902 · Decision Dec 11, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    9
    Applicant Total
    76
    Review Days
    65

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    Basic Information

    Device Name
    MODIFIED SARNS MEMBRANE OXYGENATOR
    K Number
    K863902
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    3M Health Care, Sarns
    Date Received
    October 7, 1986
    Decision Date
    December 11, 1986
    Product Code
    DTX
    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
    DTX Gas Control Unit, Cardiopulmonary Bypass

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