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510(k) Data Aggregation

    K Number
    K043328
    Device Name
    MICROFLO-SAFE SCALP VEIN SET
    Date Cleared
    2005-04-15

    (134 days)

    Product Code
    Regulation Number
    880.5440
    Why did this record match?
    Applicant Name (Manufacturer) :

    DKS LOVERSAN INDUSTRIA BIOMEDICA SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. This device may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
    Device Description
    The MICROFLO-SAFE Scalp Vein Set is a winged blood collection needle intended for veinpuncture to collect blood specimens for patients. It is also indicated for intravenous administration of fluids after removing the attached luer adaptor from the blood collection set connector and attaching a syringe, or other compatible/appropriate device. Additionally, after withdraw of the needle from the patient's vein, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
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