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510(k) Data Aggregation

    K Number
    K232536
    Device Name
    Soldier Microcatheter
    Manufacturer
    Embolx, Inc.
    Date Cleared
    2024-02-23

    (186 days)

    Product Code
    DQO
    Regulation Number
    870.1200
    Why did this record match?
    Applicant Name (Manufacturer) :

    Embolx, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Soldier Microcatheter is indicated for use in the blood vessels of the peripheral vasculature. It is intended to assist in the delivery of diagnostic agents and therapeutic agents into the target treatment area. The Soldier Microcatheter is intended for Prescription Use Only.
    Device Description
    The Soldier is a single lumen catheter designed to access small, tortuous vasculature. It is available in a variety of outer and inner diameters. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with lubricious PTFE to facilitate movement of guidewires and other devices. The distal tip of the catheter is radiopaque to aid in visualization under fluoroscopy.
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    K Number
    K180904
    Device Name
    Sniper Infusion Catheter with Balloon Occlusion
    Manufacturer
    Embolx, Inc
    Date Cleared
    2018-06-08

    (63 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    Embolx, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sniper Infusion Catheter with Balloon Occlusion is intended for use in the peripheral vasculature where temporary occlusion is desired and offers vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Sniper Infusion Catheter with Balloon Occlusion is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.
    Device Description
    The Sniper" Infusion Catheter with Balloon Occlusion is a coaxial dual lumen catheter with an occlusion balloon located at the distal end to provide temporary complete occlusion or limitation of blood flow in peripheral blood vessels as well as provide a delivery conduit for diagnostic agents such as contrast media and therapeutic agents such as embolization particles into the peripheral vasculature. One lumen is dedicated to balloon inflation and deflation, the other lumen is intended to accommodate the guide wire and delivery of fluids and other diagnostic and therapeutic agents. Device placement in the target location is achieved using a guiding catheter that has been placed through an introducer. A guidewire is threaded through the device's lumen for navigating the device to the selected vessel location. Device visualization is provided by two radiopaque bands using fluoroscopy. One radiopaque band is located on the distal tip of the device, and one on the distal end of the balloon, which is 1 cm proximal to the distal tip. Through the guidewire (perfusion) lumen, the clinician can deliver diagnostic or therapeutic agents into the selected blood vessel. After treatment, the balloon is deflated and blood flow resumes. The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by ETO and is intended for single use.
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    K Number
    K142692
    Device Name
    Occlusion Balloon Catheter
    Manufacturer
    EMBOLX, INC.
    Date Cleared
    2015-05-31

    (251 days)

    Product Code
    MJN
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMBOLX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Embolx Occlusion Balloon Catheter is intended for use in the peripheral vasculature where temporary occlusion is desired and offers a vessel selective technique of temporary vascular occlusion for selectively stopping or controlling blood flow. The Embolx Occlusion Catheter is also intended to assist in the delivery of diagnostic agents such as contrast media and therapeutic agents into the peripheral vasculature.
    Device Description
    The Embolx Occlusion Balloon Catheter is a coaxial dual lumen device that consists of an occlusion balloon at the distal end with two embedded radiopaque bands to allow for visualization and positioning of the device under fluoroscopic guidance. The proximal hub consists of two ports: one port for use by the guidewire and delivery of fluids and the second port for inflation and deflation of the balloon. The low profile balloon is manufactured of a compliant material that allows ease of insertion and withdrawal from the vasculature and conforms to the vessel wall. The balloon is inflated and deflated with a hand held syringe. The device is supplied sterile by EtO and is intended for single use. The occlusion catheter has an outside diameter of 2.9F proximally and 2.2F distally. The occlusion balloon on the distal end can be inflated up to 5mm in diameter and 11mm in length. The usable length of the device is 110cm. The device can withstand an infusion pressure up to 900 psi.
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