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510(k) Data Aggregation

    K Number
    K081942
    Device Name
    NEUROCATH AG
    Manufacturer
    VYGON NEURO
    Date Cleared
    2008-08-12

    (35 days)

    Product Code
    JXG, DEV
    Regulation Number
    882.5550
    Why did this record match?
    Applicant Name (Manufacturer) :

    VYGON NEURO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Neurocath Ag catheter is designed to be temporarily implanted (less than 30 days) for the drainage of cerebrospinal fluid (CSF) to reduce and control increased intracranial pressure.
    Device Description
    The Neurocath Ag is an external drainage catheter composed of polyurethane and impregnated with the silver ions for the purpose of radionacity. The catheter is available with 3 holes off-set at 120" or 16 holes, in lengths of 32, 23.5, and 15.5cm. Biocompatibility and performance testing demonstrates the safety and efficacy of these devices. The Neurocath Ag is supplied with a stainless steel stylet (for introducing it into the ventricle), a stainless steel subgaleal trochar (for tunneled catheter placement), a male luer connector, a slitted wing and a compression hub (for connecting the cathetex to the tubing set). The Neurocath Ag eatherer is available individually or packaged with the tubing set.
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