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

    18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II

    K Number: K073559 · Decision Jan 31, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    24
    Applicant Total
    6
    Review Days
    43

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    Basic Information

    Device Name
    18 FR. RMI ARTERIAL PERFUSION CANNULA II, 20 FR. RMI ARTERIAL PERFUSION CANNULA II
    K Number
    K073559
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Edwards Lifesciences Research Medical
    Date Received
    December 19, 2007
    Decision Date
    January 31, 2008
    Product Code
    DQR
    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
    DQR Cannula, Catheter

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