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510(k) Data Aggregation

    K Number
    K072507
    Device Name
    ENDOWAVE INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2007-10-04

    (28 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K060084
    Why did this record match?
    Reference Devices :

    K060084

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

    The EndoWave® Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    Device Description

    The system consists of a disposable infusion catheter with removable ultrasound core and an instrument that generates and controls the delivery of energy to the catheter. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor transducer temperature.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that a device meets such criteria. The document is primarily a notification from the FDA regarding an administrative change to a previously issued substantial equivalence letter for the EndoWave Infusion System. It mentions the device's intended use and briefly describes its components, but it does not detail any performance metrics, studies, or results that would correspond to the questions asked.

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