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

    EMBOTRAP III Revascularization Device

    K Number: K193063 · Decision Jul 14, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59
    Same Product Code
    108
    Applicant Total
    4
    Review Days
    253

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    Basic Information

    Device Name
    EMBOTRAP III Revascularization Device
    K Number
    K193063
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neuravi, Ltd.
    Date Received
    November 4, 2019
    Decision Date
    July 14, 2020
    Product Code
    NRY
    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
    NRY Catheter, Thrombus Retriever

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    Other Clearances by Neuravi, Ltd.

    K Number Device Name
    K212908 EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
    K211338 EMBOTRAP III Revascularization Device
    K173452 EmboTrap ll Revascularization Device