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

    AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE

    K Number: K033468 · Decision Nov 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    21
    Registration Numbers
    21
    Same Product Code
    94
    Applicant Total
    28
    Review Days
    11

    Basic Information

    Device Name
    AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
    K Number
    K033468
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.4260
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MEDTRONIC PERFUSION SYSTEMS
    Date Received
    November 3, 2003
    Decision Date
    November 14, 2003
    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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