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

    HEADWAY 27 MICROCATHETER

    K Number: K110813 · Decision Aug 5, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    271
    Registration Numbers
    272
    Same Product Code
    880
    Applicant Total
    7
    Review Days
    134

    Basic Information

    Device Name
    HEADWAY 27 MICROCATHETER
    K Number
    K110813
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MICRO VENTION, INC.
    Date Received
    March 24, 2011
    Decision Date
    August 5, 2011
    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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