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

    KODAMA INTRAVASCULAR ULRASOUND CATHETER

    K Number: K113008 · Decision Jun 14, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    77
    Applicant Total
    3
    Review Days
    251

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    Basic Information

    Device Name
    KODAMA INTRAVASCULAR ULRASOUND CATHETER
    K Number
    K113008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1200
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Silicon Vally Medical Instruments, Inc.
    Date Received
    October 7, 2011
    Decision Date
    June 14, 2012
    Product Code
    OBJ
    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
    OBJ Catheter, Ultrasound, Intravascular

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    Other Clearances by Silicon Vally Medical Instruments, Inc.

    K Number Device Name
    K122878 HD-IVUS ULTRASOUND IMAGING SYSTEM
    K112997 HD-IVUS ULTRASOUND IMAGING SYSTEM