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

    MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR

    K Number: K132369 · Decision Sep 27, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    32
    Applicant Total
    14
    Review Days
    59

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    Basic Information

    Device Name
    MAGELLAN ROBOTIC SYSTEM, MAGELLAN ROBOTIC CATHETER 9FR
    K Number
    K132369
    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
    July 30, 2013
    Decision Date
    September 27, 2013
    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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