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510(k) Data Aggregation

    K Number
    K193063
    Device Name
    EMBOTRAP III Revascularization Device
    Manufacturer
    Neuravi, Ltd.
    Date Cleared
    2020-07-14

    (253 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Neuravi, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EMBOTRAP III Revascularization Device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
    Device Description
    The EmboTrap™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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