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

    SARNS FILTERED VENOUS RESERVIOR MODIFICATION

    K Number: K941654 · Decision Jul 26, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    76
    Review Days
    112

    Basic Information

    Device Name
    SARNS FILTERED VENOUS RESERVIOR MODIFICATION
    K Number
    K941654
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    3M HEALTH CARE, SARNS
    Date Received
    April 5, 1994
    Decision Date
    July 26, 1994
    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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