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510(k) Data Aggregation

    K Number
    K031173
    Device Name
    NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013
    Manufacturer
    NEEDLETECH PRODUCTS, INC.
    Date Cleared
    2003-07-23

    (100 days)

    Product Code
    GDF
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GDF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The guidewire introducer needles are intended for use as introducers/cannula for percutaneous introduction and placement of guidewires in vascular procedures.
    Device Description
    The NeedleTech Guidewire Introducer Needle consists of a stainless steel cannula with an attached plastic luer lock hub on one end and a ground point or blunt tip on the other end. The device is intended to be supplied non-sterile and packaged in bulk.
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