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

    MICROFRANCE(R) WORMALD VASCULAR CLAMP

    K Number: K112662 · Decision Jan 20, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    186
    Registration Numbers
    186
    Same Product Code
    203
    Applicant Total
    37
    Review Days
    129

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    Basic Information

    Device Name
    MICROFRANCE(R) WORMALD VASCULAR CLAMP
    K Number
    K112662
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.4450
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medtronic Xomed, Inc.
    Date Received
    September 13, 2011
    Decision Date
    January 20, 2012
    Product Code
    DXC
    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
    DXC Clamp, Vascular

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