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510(k) Data Aggregation

    K Number
    K221163
    Device Name
    Tunnel Crossing Catheter
    Manufacturer
    Tractus Vascular, LLC
    Date Cleared
    2023-01-19

    (272 days)

    Product Code
    PDU
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    Tractus Vascular, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tunnel CC is intended to be used with a guidewire to access discrete regions of the peripheral vasculature and to facilitate the intraluminal placement of conventional guidewires beyond stenotic peripheral lesions (including chronic total occlusions) prior to placement of other interventional devices.
    Device Description
    The Tunnel CC is a single lumen, over-the-wire endovascular catheter. The design consists of a layered tubing configuration with a hydrophilic, lubricious coating on the distal end to reduce frictional forces. The center stainless steel (SS) tubing which drives functionality including buckling resistance is cut in a continuous spiral jigsaw pattern along most of the length; it ends with longitudinal laser cuts at the distal end enabling the formation of a smooth, tapered tip that is continuous with the shaft body of the catheter. This center SS tube is sandwiched between two polymer tubes where the inside layer is PTFE and the outside layer is PEBAX. A luer hub at the user end allows flushing of saline solutions or contrast media through the inner lumen and facilitates guidewire exchanges. This device comes in 0.014", 0.018" and 0.035" guidewire compatible sizes and lengths of 90cm, 135-cm, 155-cm and 170-cm for each quidewire size. The catheters are used to navigate tortuous peripheral vasculature while providing axial stability to enhance guidewire and device crossing of discrete lesions of the peripheral vasculature. The catheters are also used to allow for guidewire exchanges and provide a conduit for delivering saline solutions and contrast media.
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