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

    OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER

    K Number: K141769 · Decision Aug 18, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    10
    Review Days
    48

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    Basic Information

    Device Name
    OPTIS INTEGRATED SYSTEM, DRAGONFLY OPTIS IMAGING CATHETER
    K Number
    K141769
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lightlab Imaging, Inc.
    Date Received
    July 1, 2014
    Decision Date
    August 18, 2014
    Product Code
    DQO
    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
    DQO Catheter, Intravascular, Diagnostic

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