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

    Navien Intracranial Support Catheter

    K Number: K161152 · Decision Oct 12, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    32
    Review Days
    170

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    Basic Information

    Device Name
    Navien Intracranial Support Catheter
    K Number
    K161152
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Received
    April 25, 2016
    Decision Date
    October 12, 2016
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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