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

    MODIFICATION TO:CONTOUR SE MICROSPHERES

    K Number: K071634 · Decision Jul 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    432
    Review Days
    27

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    Basic Information

    Device Name
    MODIFICATION TO:CONTOUR SE MICROSPHERES
    K Number
    K071634
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    June 15, 2007
    Decision Date
    July 12, 2007
    Product Code
    HCG
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HCG Device, Neurovascular Embolization

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