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510(k) Data Aggregation

    K Number
    K062508
    Device Name
    NEUROWAVE MICRO-INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2006-12-05

    (99 days)

    Product Code
    NUI
    Regulation Number
    870.1200
    Why did this record match?
    Product Code :

    NUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
    Device Description
    The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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    K Number
    K053437
    Device Name
    EKOS MICRO-INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2006-01-06

    (28 days)

    Product Code
    NUI
    Regulation Number
    870.1200
    Why did this record match?
    Product Code :

    NUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EKOS Micro- Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
    Device Description
    The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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    K Number
    K051225
    Device Name
    EKOS MICRO-INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2005-06-10

    (29 days)

    Product Code
    NUI
    Regulation Number
    870.1200
    Why did this record match?
    Product Code :

    NUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EKOS Micro-Infusion System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature. The EKOS Micro- Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro- Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
    Device Description
    The system consists of a disposable infusion/ultrasound catheter and an instrument that generates and controls the delivery of energy to the catheter. The catheter contains a single ultrasound transducer, located at the distal tip, a thermal sensor and a distal end hole for placement over a guide wire and fluid infusion.
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    K Number
    K041826
    Device Name
    EKOS ULTRASOUND INFUSION SYSTEM
    Manufacturer
    EKOS CORP.
    Date Cleared
    2005-04-27

    (294 days)

    Product Code
    NUI
    Regulation Number
    870.1200
    Why did this record match?
    Product Code :

    NUI

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EKOS Micro-Infusion System is intended for regional infusion of contrast materials into selected vessels in the neurovasculature. The EKOS Micro-Infusion System may be used for controlled, regional infusion into selected vessels and is not intended for use in the coronary vasculature.
    Device Description
    The EKOS Micro-Infusion System is an infusion catheter system designed to deliver ultrasound energy through a transducer element at the distal catheter tip. This device is intended to deliver angiographic contrast material into the neurovasculature.
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