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

    COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER

    K Number: K902437 · Decision Dec 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    33
    Applicant Total
    77
    Review Days
    196

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    Basic Information

    Device Name
    COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER
    K Number
    K902437
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4230
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cobe Laboratories, Inc.
    Date Received
    June 4, 1990
    Decision Date
    December 17, 1990
    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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