BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    ENDOHELIX ENDARTERECTOMY DEVICE

    K Number: K032105 · Decision Oct 30, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    13
    Applicant Total
    1
    Review Days
    114

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    Basic Information

    Device Name
    ENDOHELIX ENDARTERECTOMY DEVICE
    K Number
    K032105
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4875
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endarx, Inc.
    Date Received
    July 8, 2003
    Decision Date
    October 30, 2003
    Product Code
    DWX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DWX Stripper, Artery, Intraluminal

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