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510(k) Data Aggregation

    K Number
    K172035
    Device Name
    EKOS ultrasound EVD Device, EVD Control Unit
    Manufacturer
    BTG International, Inc.
    Date Cleared
    2018-03-24

    (262 days)

    Product Code
    JXG,HCA
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EKOS Ultrasound EVD System is intended to be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) as a means of reducing intracranial pressure and CSF volume.

    Device Description

    Not Found

    AI/ML Overview

    This is a 510(k) premarket notification for the EKOS Ultrasound EVD System, which is a ventricular catheter. The document does not describe the acceptance criteria or a study proving the device meets those criteria. It is a regulatory letter from the FDA confirming substantial equivalence to legally marketed predicate devices and outlining general controls and regulations.

    Therefore, I cannot provide the requested information from the provided text.

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