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    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    Foresight Intracardiac Echocardiography (ICE) System

    K Number: K151126 · Decision Dec 18, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    210
    Registration Numbers
    211
    Same Product Code
    499
    Applicant Total
    1
    Review Days
    234

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    Basic Information

    Device Name
    Foresight Intracardiac Echocardiography (ICE) System
    K Number
    K151126
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Colibri Technologies, Inc.
    Date Received
    April 28, 2015
    Decision Date
    December 18, 2015
    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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