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510(k) Data Aggregation

    K Number
    K130714
    Device Name
    PROGIGY SUPPORT CATHETER
    Manufacturer
    RADIUS MEDICAL, LLC
    Date Cleared
    2013-08-22

    (160 days)

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

    RADIUS MEDICAL, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Prodigy Support Catheter is intended to be used in conjunction with steerable guidewires in order to access discrete regions of the arterial and or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
    Device Description
    The Prodigy Support Catheter is an over-the-wire (OTW) 2-lumen catheter with a 5 mm clastomeric balloon located near the distal tip. One lumen of the catheter is used to inflate and deflate the balloon with contrast fluid. The second lumen provides access for a guidewire. Two side legs are located at the proximal catheter end to provide access to the balloon lumen and the guidewire lumcu. A pressure relief valve is attached at the proximal end of the balloon side leg and allows for connection with an inflation device. There are two radiopaque marker bands located at each end of the balloon. The inflated balloon diameter is variable with increased pressure up to 5 mm. The Prodigy Support Catheter is packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-6.
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