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

    INTERFACE PRE BYPASS PRIME FILTER #90

    K Number: K812244 · Decision Aug 25, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    23
    Applicant Total
    21
    Review Days
    14

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    Basic Information

    Device Name
    INTERFACE PRE BYPASS PRIME FILTER #90
    K Number
    K812244
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Medical, Inc.
    Date Received
    August 11, 1981
    Decision Date
    August 25, 1981
    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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