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

    Trevo NXT ProVue Retriever

    K Number: K210502 · Decision Aug 27, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    32
    Review Days
    186

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    Basic Information

    Device Name
    Trevo NXT ProVue Retriever
    K Number
    K210502
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Neurovascular
    Date Received
    February 22, 2021
    Decision Date
    August 27, 2021
    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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