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

    ARTISAN EXTEND CONTROL CATHETER

    K Number: K122275 · Decision Aug 29, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    3
    Review Days
    30

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    Basic Information

    Device Name
    ARTISAN EXTEND CONTROL CATHETER
    K Number
    K122275
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Hansen Medical
    Date Received
    July 30, 2012
    Decision Date
    August 29, 2012
    Product Code
    DRA
    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
    DRA Catheter, Steerable

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    Other Clearances by Hansen Medical

    K Number Device Name
    K141614 MAGELLAN ROBOTIC SYSTEM
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