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510(k) Data Aggregation

    K Number
    K193278
    Device Name
    MedSource CathMED IV Catheter
    Manufacturer
    Date Cleared
    2020-08-07

    (254 days)

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

    MedSource Labs

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MedSource CathMed IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
    Device Description
    The MedSource CathMED IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource CathMED IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy. Each MedSource CathMED IV Catheter is comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, Teflon catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The MedSource CathMED IV Catheter components combine for an ergonomic design. The device inserts a catheter intravenously by inserting a sharp needle with an over-theneedle catheter. Once the needle and catheter have been passed into a vein the catheter can be advance off the needle is the needle is removed while the catheter remains in the vein for short term use to sample blood or administer fluids. The MedSource CathMED IV Catheter gauges are color coded for positive identification and range from 14G to 24G ORANGE = 14G GREY = 16G GREEN = 18G PINK = 20G BLUE = 22G YELLOW = 24G
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