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

    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter

    K Number: K181042 · Decision May 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    77
    Applicant Total
    193
    Review Days
    28

    Basic Information

    Device Name
    Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter
    K Number
    K181042
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2330
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corporation
    Date Received
    April 19, 2018
    Decision Date
    May 17, 2018
    Product Code
    DXK
    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
    DXK Echocardiograph

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