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510(k) Data Aggregation

    K Number
    K060084
    Device Name
    LYSUS INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2006-02-07

    (27 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K052071
    Predicate For
    K062507,K062508
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Lysus® 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 the provided text does not contain information about the acceptance criteria or a study proving the device meets those criteria. The documents are FDA letters regarding a 510(k) premarket notification for the Lysus Infusion System. They confirm substantial equivalence to a predicate device and provide administrative details, but do not outline performance acceptance criteria or study results.

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