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

    INTERSEPT 40 MICRON FILTER W/TUBING

    K Number: K833476 · Decision Dec 27, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    95
    Applicant Total
    69
    Review Days
    81

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    Basic Information

    Device Name
    INTERSEPT 40 MICRON FILTER W/TUBING
    K Number
    K833476
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Extracorporeal Medical Specialities, Inc.
    Date Received
    October 7, 1983
    Decision Date
    December 27, 1983
    Product Code
    DTM
    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
    DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line

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