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510(k) Data Aggregation

    K Number
    K220866
    Device Name
    EKOS+ Endovascular Device
    Manufacturer
    Boston Scientific
    Date Cleared
    2022-04-20

    (26 days)

    Product Code
    QEY,KRA
    Regulation Number
    870.5150
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K213422
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EKOS+ Endovascular System is indicated for the:

    • Ultrasound facilitated, controlled and selective intravascular infusion of physician-specified fluids, including thrombolytics, for the treatment of pulmonary embolism and/or deep vein thrombosis.
    • Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the pulmonary arteries and/or peripheral vasculature.
    Device Description

    The EKOS+ Endovascular System consists of an EKOS+ Endovascular Device and EKOS Control Unit (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 20 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.

    AI/ML Overview

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