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

    SENSEI X ROBOTIC CATHETER SYSTEM

    K Number: K102168 · Decision Oct 22, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    32
    Applicant Total
    14
    Review Days
    81

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    Basic Information

    Device Name
    SENSEI X ROBOTIC CATHETER SYSTEM
    K Number
    K102168
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1290
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hansen Medical, Inc.
    Date Received
    August 2, 2010
    Decision Date
    October 22, 2010
    Product Code
    DXX
    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
    DXX System, Catheter Control, Steerable

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