BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇪 Ireland

    pRESET Thrombectomy Device

    K Number: K222848 · Decision Jan 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    17
    Applicant Total
    4
    Review Days
    121

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    Basic Information

    Device Name
    pRESET Thrombectomy Device
    K Number
    K222848
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5600
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Phenox Limited
    Date Received
    September 21, 2022
    Decision Date
    January 20, 2023
    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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    Other Clearances by Phenox Limited

    K Number Device Name
    K242676 pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device
    K231539 pRESET LITE Thrombectomy Device
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