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510(k) Data Aggregation

    K Number
    K140151
    Device Name
    EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
    Manufacturer
    BTG INTERNATIONAL, INC.
    Date Cleared
    2014-05-21

    (119 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EkoSonice Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text does not contain information about the acceptance criteria, device performance, or any study details. The documents are standard FDA 510(k) clearance letters for the EkoSonic Endovascular System, primarily focused on administrative changes, regulatory classification, and indications for use. There is no information in these documents about how the device meets acceptance criteria or details of a study proving its performance.

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