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510(k) Data Aggregation

    K Number
    K191119
    Device Name
    EkoSonic Endovascular Device
    Manufacturer
    BTG International, Inc.
    Date Cleared
    2019-08-23

    (119 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EkoSonic® Endovascular System is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
    Device Description
    The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and the Control System (Control Unit 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 30 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. This notification is being made due to the modification of the MSD hub portion of the EkoSonic Endovascular Device.
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    K Number
    K183361
    Device Name
    EkoSonic Endovascular Device with Control Unit 4.0
    Manufacturer
    BTG International, Inc.
    Date Cleared
    2019-04-05

    (122 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EkoSonic Endovascular Device with Control Unit 4.0 is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
    Device Description
    The EkoSonic Endovascular Device with CU 4.0 consists of an EkoSonic Endovascular Device and the Control System 4.0 (Control Unit 4.0 and Connector Interface Cables). The EkoSonic Endovascular Device consists of a 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 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone. It is the modifications to the Control System 4.0 that are the subject of this submission.
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    K Number
    K182324
    Device Name
    EkoSonic Endovascular System
    Manufacturer
    BTG International, Inc.
    Date Cleared
    2018-11-26

    (91 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EkoSonic Endovascular System is indicated for the: - Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - Infusion of solutions into the pulmonary arteries. - Controlled and selective infusion of physician-specified fluids, into the peripheral vasculature.
    Device Description
    Not Found
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    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    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
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    K Number
    K162771
    Device Name
    EkoSonic Endovascular System with Control Unit 4.0
    Manufacturer
    BTG International, Inc.
    Date Cleared
    2017-02-24

    (144 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG International, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EkoSonic® Endovascular System is indicated for the: - · Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism. - · Infusion of solutions into the pulmonary arteries. - · Controlled and selective infusion of physician-specified fluids, into the peripheral vasculature.
    Device Description
    The EkoSonic Endovascular System consists of an EkoSonic Device and the Control Unit 4.0 (CU 4.0). The EkoSonic Device consists of a 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 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The CU 4.0 generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
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    K Number
    K140151
    Device Name
    EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
    Manufacturer
    BTG INTERNATIONAL, INC.
    Date Cleared
    2014-05-21

    (119 days)

    Product Code
    QEY, KRA
    Regulation Number
    870.5150
    Why did this record match?
    Applicant Name (Manufacturer) :

    BTG INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EkoSonice Endovascular System is indicated for the ultrasound facilitated, controlled and selective infusion of physicianspecified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
    Device Description
    Not Found
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