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510(k) Data Aggregation

    K Number
    K213466
    Device Name
    Houdini Cross Support Catheter
    Date Cleared
    2022-10-20

    (357 days)

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

    Cruzar Medsystems Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Houdini Cross Support Catheter is intended to be used in conjunction with a steerable guidewire to access discrete regions of the peripheral vasculature and for guidewire exchange.
    Device Description
    The Houdini® Cross Support Catheter is a single use, bi-lumen intravascular catheter intended for percutaneous use. The Houdini® Cross Support Catheter is intended for use in the iliac. femoral, ilio-femoral and popliteal arteries. It is designed for use in conjunction with a standard commercially available off the shelf (OTS) 0.014" - 0.018" quidewire (not included) to gain access to locations within the cardiovascular system that are remote from the site of insertion. Once accessed, guidewires may be exchanged within the catheter. In addition, the Houdini® Cross Support Catheter provides the option of distal anchoring as well as physician-controlled extension of the inner shaft (up to 2 cm) to support the OTS guidewire during advancement. The effective length of the Houdini® Cross Support Catheter is a nominal 100 cm. The inner lumen accommodates an OTS 0.014" - 0.018" spring-tipped guidewire. The inner lumen shaft allows for visualization under fluoroscopy due to the radiopague stainlesssteel design and additionally allows for continuous clinician control of the OTS guidewire for appropriate positioning. If distal anchoring is desired, the Houdini® Cross Support Catheter requires the use of a commercially available OTS manual inflation device (not included). Once positioned within 2 cm of the user's target location, the catheter is inflated to 6 atm using diluted radiopaque contrast media to anchor the distal end of the catheter in the blood vessel. For additional support of the quidewire, the clinician may extend the location of the inner lumen shaft up to 2 cm distally without the need to reposition the anchoring balloon.
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