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510(k) Data Aggregation

    K Number
    K073471
    Device Name
    VANTAGECATH INTRAVASCULAR CATHETER
    Date Cleared
    2008-04-30

    (141 days)

    Product Code
    Regulation Number
    880.5200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ADVANTAGE MEDICAL DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VantageCath™ is a short-term intravascular catheter which allows health care practitioner to sample blood and administer fluids or medication intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused, and the duration of therapy. The VantageCath™ catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the needle retracts into the needle-shielding barrel, the catheter hub and needle assembly components are automatically separated.
    Device Description
    The VantageCath™ is a short-term intravascular catheter that includes a needle-shielding feature. After threading the catheter into the vein, the sharps safety feature is activated and the needle is retracted into the cylindrical needle shield. The catheter hub and needle assembly components are automatically separated. It is manufactured with conventional medical grade, biocompatible materials. It operates as a safety device by providing a sharps safety feature, thus minimizing the opportunity for accidental needle sticks. It is supplied sterile for single use only.
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