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

    SARNS NON-FILTERED VENOUS RESERVOIR

    K Number: K912915 · Decision Sep 25, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    49
    Review Days
    84

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    Basic Information

    Device Name
    SARNS NON-FILTERED VENOUS RESERVOIR
    K Number
    K912915
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    3M Health Care, Ltd.
    Date Received
    July 3, 1991
    Decision Date
    September 25, 1991
    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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