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

    Solitaire 2 and Solitaire Platinum Revascularization Device

    K Number: K181060 · Decision Aug 24, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    1
    Review Days
    123

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    Basic Information

    Device Name
    Solitaire 2 and Solitaire Platinum Revascularization Device
    K Number
    K181060
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Neurovascular
    Date Received
    April 23, 2018
    Decision Date
    August 24, 2018
    Product Code
    POL
    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
    POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

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