LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K032105
    Device Name
    ENDOHELIX ENDARTERECTOMY DEVICE
    Manufacturer
    ENDARX, INC.
    Date Cleared
    2003-10-30

    (114 days)

    Product Code
    DWX
    Regulation Number
    870.4875
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDARX, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.
    Device Description
    The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire. The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.
    Ask a Question

    Page 1 of 1