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

    COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER

    K Number: K850139 · Decision Apr 10, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    COBE COP FILTER CARDIOPULMONARY PREBYPASS FILTER
    K Number
    K850139
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Rapid Diagnostic Laboratories, Inc.
    Date Received
    January 14, 1985
    Decision Date
    April 10, 1985
    Product Code
    KRJ
    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
    KRJ Filter, Prebypass, Cardiopulmonary Bypass

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