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510(k) Data Aggregation

    K Number
    K122152
    Device Name
    OXTI INFLATION DEVICE
    Manufacturer
    Date Cleared
    2012-12-14

    (147 days)

    Product Code
    Regulation Number
    870.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    OXTI CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in a balloon dilation catheter.
    Device Description
    The device consists of three major components; a) 30ml barrel, b) inflation mechanism and c) 6% standard conical fitting and stopcocks system for connecting to the PTCA catheter. The barrel has graduation markings at 0.5ml interval to the full 30ml capacity A dual scale pressure gauge mounted at distal end of the barrel is capable of indicating pressure up to 30atm at 1atm or 10psi intervals. Reinforced polyurethane tubing extending from the svringe exit port connects to a 6% male/female conical fitting for attaching to the 3-way stopcock and to the angiographic catheter.
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