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

    EMBA Hourglass Peripheral Embolization Device

    K Number: K171845 · Decision Aug 18, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    103
    Registration Numbers
    103
    Same Product Code
    128
    Applicant Total
    1
    Review Days
    59

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    Basic Information

    Device Name
    EMBA Hourglass Peripheral Embolization Device
    K Number
    K171845
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3300
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Emba Medical Limited
    Date Received
    June 20, 2017
    Decision Date
    August 18, 2017
    Product Code
    KRD
    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
    KRD Device, Vascular, For Promoting Embolization

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