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510(k) Data Aggregation

    K Number
    K210339
    Device Name
    Bullfrog Micro-Infusion Device
    Manufacturer
    Mercator MedSystems, Inc.
    Date Cleared
    2021-08-02

    (178 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mercator MedSystems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Bullfrog devices capable of treating <6 mm diameter vessels: In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally. For Bullfrog devices capable only of treating ≥6 mm diameter vessels: In selective areas of peripheral vessels, the Bullfrog Micro-Infusion Device is intended for infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.
    Device Description
    The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
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    K Number
    K161402
    Device Name
    Bullfrog Micro-Infusion Device
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Date Cleared
    2016-08-18

    (90 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCATOR MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents into the vessel wall and perivascular area, or intraluminally.
    Device Description
    The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
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    K Number
    K153501
    Device Name
    Bullfrog Micro-Infusion Device
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Date Cleared
    2016-04-15

    (130 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCATOR MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In selective areas of peripheral and coronary vessels, the Bullfrog Micro-Infusion Device is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The Bullfrog Micro-Infusion Device is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
    Device Description
    The Mercator MedSystems Bullfrog Micro-Infusion Device is a wire-guided, singleoperator, endovascular catheter that consists of a perpendicular microneedle, which is sheathed by and contained within a semi-rigid polymer actuator balloon. The device is designed to be advanced to target vasculature and hydraulically actuated to move the microneedle through the external elastic lamina to deliver substances to adventitial and perivascular tissues. A compliant stabilizing balloon inflates with the actuator to provide a force opposite the needle tip for proper seating of the needle is retracted within the sheathing structure by vacuuming the hydraulic actuator.
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    K Number
    K131401
    Device Name
    BLOWFISH TRANSBRONCHIAL MICRO-INFUSION CATHETER
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Date Cleared
    2013-07-02

    (48 days)

    Product Code
    EOQ
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCATOR MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Blowfish™ Transbronchial Micro-Infusion Catheter is intended to deliver therapeutic and diagnostic agents that are indicated or labeled for airway, tracheal or bronchial delivery into selected and sub-selected regions of the airway tree.
    Device Description
    The Blowfish™ Transbronchial Micro-Infusion Catheter is a bronchoscope guided, single-operator, catheter that consists of a microscopic, tapered stainless steel infusion port, a semi-rigid/semi-elastic polymer balloon, a composite metal and polymer catheter shaft, a pressure relief valve and a proximal hub with standard luer attachment fittings. The device is designed to be advanced through a bronchoscope to a target location in the tracheobronchial three and inflated to move the micro-infusion port into the airway wall to deliver therapeutics to the bronchial tissue including the bronchial adventitia.
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    K Number
    K062752
    Device Name
    MERCATOR MICROSYRINGE II INFUSION CATHETER
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Date Cleared
    2006-12-07

    (84 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Why did this record match?
    Applicant Name (Manufacturer) :

    MERCATOR MEDSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.
    Device Description
    The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to ctructures structures.
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