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510(k) Data Aggregation

    K Number
    K051519
    Device Name
    FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)
    Manufacturer
    ABBOTT LABORATORIES (PERCLOSE, INC.)
    Date Cleared
    2005-06-21

    (13 days)

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

    ABBOTT LABORATORIES (PERCLOSE, INC.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Fox SV PTA Catheter is intended for dilatation of lesions in the femoral, renal, iliac, popliteal, peroneal, and profunda arteries and native or synthetic arteriovenous dialysis fistulae. This catheter is not intended for the delivery or expansion of stents.
    Device Description
    The Fox SV PTA Catheter is a standard over-the-wire PTA catheter. The double lumen catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the second lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon material expands to a known diameter at specific pressure.
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