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510(k) Data Aggregation

    K Number
    K214106
    Device Name
    QuikPass Catheter
    Date Cleared
    2022-01-28

    (30 days)

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

    Traverse Vascular, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.
    Device Description
    The QuikPass Catheter is comprised of a proximal end containing a Luer connection and hub, a single-lumen shaft with radiopaque markers at the distal end, and a tapered distal tip with oval ports at 60° intervals. The single-lumen shaft of the QuikPass Catheter is constructed of two polymer layers that encapsulate a braid and coil affording increased tensile strength and torque transmission. The distal 40cm of the catheter has a hydrophilic coating to aid in navigating the device through the vasculature to the target location. The QuikPass Catheter is available in both 3 French and 4 French outer diameter sizes. Each version is available in 135cm and 150cm lengths, providing a total of four models. All models of the QuikPass Catheter are sold sterile. Sterility is achieved using ethylene oxide.
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