LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K140576
    Device Name
    Y WIRE 2
    Manufacturer
    SAFEWIRE, LLC
    Date Cleared
    2014-05-20

    (75 days)

    Product Code
    HXI
    Regulation Number
    888.4540
    Why did this record match?
    Applicant Name (Manufacturer) :

    SAFEWIRE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Y - Wire2 guidewire is intended for use by surgeons to assist with the proper introduction and placement of orthopedic instruments and implants.
    Device Description
    The Y-Wire 2 is an orthopedic guidewire with a distinctive distal split tip that is designed to prevent inadvertent advancement of the wire in tissue. Upon exiting a cannula, the distal tips will deploy to stop further advancement past the desired location. By design the distal tip is splayed 300 decrees for a distance of 11mm. The guidwire is made of Nitinol. The Y-Wire 2 is manufactured in five (5) diameters: 1.10mm, 1.40mm, 1.45mm and 1.50mm all have the same length of 560mm.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1