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510(k) Data Aggregation

    K Number
    K113225
    Device Name
    NYLUS PICC
    Manufacturer
    SEMPRUS BIOSCIENCES
    Date Cleared
    2012-11-06

    (371 days)

    Product Code
    LJS, THE
    Regulation Number
    880.5970
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    Applicant Name (Manufacturer) :

    SEMPRUS BIOSCIENCES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nylus™ PICC is intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days. The device has a maximum recommended infusion rating of 5mL/sec.
    Device Description
    The Nylus™ PICC is a 5Fr, dual-lumen Peripherally Inserted Central Catheter. The Nylus PICC is a device intended to provide peripheral access to the central venous system for infusion, intravenous therapy, blood sampling, central venous pressure monitoring and power injection of contrast media. The Nylus PICC is indicated for dwell times shorter or greater than 30 days. The Nylus PICC is made from polyurethane and is approximately 60cm long. It has a reversetapered catheter design, with an injection-molded hub and extension lines with Luer Lock fittings for access attachment. Further, the Nylus PICC has been tested to withstand pressure injection at 5ml/sec with a maximum power injector pressure of 300psi. The catheter's interior and exterior surfaces have been modified by Semprus Sustain™ Technology. The Semprus Sustain Technology is a proprietary biomimetic polymer surface modification intended to reduce platelet adhesion and thrombus accumulation. The Semprus Sustain Technology does not contain or release any active agents. In vitro and short term, i.e. 4-hour in vivo acute animal studies have demonstrated a reduction in adhered platelets and thrombus accumulation on the surface of the Nylus PICC when compared to an unmodified catheter. Preclinical in vitro and animal models do not necessarily predict clinical performance with respect to thrombus accumulation.
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