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

    Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter

    K Number: K150107 · Decision Jul 29, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    1
    Review Days
    190

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    Basic Information

    Device Name
    Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
    K Number
    K150107
    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 Dba Ev3 Neurovascular
    Date Received
    January 20, 2015
    Decision Date
    July 29, 2015
    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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