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510(k) Data Aggregation

    K Number
    K212908
    Device Name
    EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device
    Manufacturer
    Date Cleared
    2021-10-13

    (30 days)

    Product Code
    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 II 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. 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® II and EMBOTRAP™ III Revascularization Devices are composed of a retrievable, selfexpanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. They are designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap® II and EMBOTRAP™ III Revascularization Devices are supplied sterile and are intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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    K Number
    K211338
    Device Name
    EMBOTRAP III Revascularization Device
    Manufacturer
    Date Cleared
    2021-07-30

    (88 days)

    Product Code
    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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    K Number
    K173452
    Device Name
    EmboTrap ll Revascularization Device
    Manufacturer
    Date Cleared
    2018-05-09

    (184 days)

    Product Code
    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® II 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® II 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® II 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. It is indicated for patients who are ineligible for intravenous tissue plasogen activator (IV t-PA) or who fail IV t-PA therapy.
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