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510(k) Data Aggregation

    K Number
    K162522
    Device Name
    UltraCath Continuous Nerve block Catheter
    Date Cleared
    2017-03-17

    (189 days)

    Product Code
    Regulation Number
    868.5120
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEFLEX MEDICAL , INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Arrow UltraCath Continuous Nerve block Catheter is placed next to nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.
    Device Description
    Stimulating continuous nerve block catheters consist of a stainless steel spring coil encased in a polyurethane outer jacket. The inner spring coil contributes a kink-resistance nature to the catheter when bent through small radii, and in stimulating catheters provides electrical conductivity. A ribbon wire is welded to both the proximal and distal ends of the inside of the coil to prevent stretching. The coils of the main catheter body are tightly wound axially (small pitch), with zero space between adjacent coils. The catheter tip is visible under ultrasound. The plastic jacket of the Conductive Resin Tip UltraCath Continuous Nerve Block Catheter is made of transparent resin and the catheter tip is made of black electrically conductive resin that covers the internal stainless steel spring coil and seals the system against undesired fluid or air ingress or egress. Anesthetics are distributed into the patient body through a single end hole located at the catheter distal end. The catheter distal tip is made of electrically conductive resin which provides an electrical contact point. The distal end of the catheter is printed with centimeter markings to aid in depth determination during catheter insertion. There is also printed distance indicator at proximal end in order to indicate proper catheter insertion inside the adaptor. A stylet placed inside the catheter's spring coil provides stiffness during the insertion procedure.
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    K Number
    K141353
    Device Name
    HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR
    Date Cleared
    2014-08-01

    (70 days)

    Product Code
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    TELEFLEX MEDICAL , INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Hudson RCI® AquaPak® Prefilled Humidifier adds humidity to a patient's breathing gases.
    Device Description
    Hudson RCI® AquaPak® Prefilled Humidifiers add water vapor (molecular H₂O) to a dry medical gas that is suspended in the gas to be inhaled by the patient. The Hudson RCI® AquaPak® Prefilled Humidifiers are designed to add humidity to inspired gas, helping to control the drying and irritation of the respiratory mucosa. The humidifiers feature a micro-diffuser that produces smaller bubbles and greater surface agitation, allowing for a quiet operation and therapeutic humidity output. Prefilled sterile reservoirs for AquaPak® Humidifiers come in four sizes; 190ml, 340ml, 540ml and 650ml. Each reservoir must be used with a suitable adaptor component, which connects the system to a flow-metered gas source and provides humidifier functionality. Adaptor types provided with Hudson RC1® AquaPak® Prefilled Humidifiers feature an audible pressure relief valve, which indicates a restriction of gas flow to the user.
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