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

    QUADRASPHERE 30 TO 60

    K Number: K113822 · Decision Mar 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    62
    Registration Numbers
    62
    Same Product Code
    184
    Applicant Total
    6
    Review Days
    72

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    Basic Information

    Device Name
    QUADRASPHERE 30 TO 60
    K Number
    K113822
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    882.5950
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosphere Medical, Inc.
    Date Received
    December 27, 2011
    Decision Date
    March 8, 2012
    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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