LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K130873
    Device Name
    VWING VASCULAR NEEDLE GUIDE, 4MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 6MM X 07MM; VWING VASCULAR NEEDLE GUIDE, 8MM X 07M
    Manufacturer
    VITAL ACCESS
    Date Cleared
    2013-09-13

    (168 days)

    Product Code
    PFH
    Regulation Number
    876.5540
    Why did this record match?
    Product Code :

    PFH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The VWING Vascular Needle Guide is indicated for use as an access device accessory on arteriovenous fistulas (AVF) for hemodialysis procedures using a constant site or "buttonhole" method of needle insertion.
    Device Description
    The VWING vascular needle guide has been designed to facilitate repeated needle access to the vasculature. The VWING vascular needle guide is an accessory for constant site or "buttonhole" method of needle insertion and is indicated for use for patient therapies requiring repeated access to the vascular system. such as hemodialysis. It is a single piece of titanium device that is implanted subcutaneously and attached to the outside of the vasculature, including on arteriovenous fistulae (AVF). The VWING acts as a guide for needles and accommodates currently available 15-17 gage needles to accurately cannulate the targeted vessel.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1