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

    HEPASPHERE MICROSPHERES

    K Number: K052742 · Decision Nov 7, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    6
    Review Days
    403

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    Basic Information

    Device Name
    HEPASPHERE MICROSPHERES
    K Number
    K052742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosphere Medical, Inc.
    Date Received
    September 30, 2005
    Decision Date
    November 7, 2006
    Product Code
    KRD
    Advisory Committee
    Cardiovascular
    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
    KRD Device, Vascular, For Promoting Embolization

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