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

    SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

    K Number: K012512 · Decision Jun 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    309

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    Basic Information

    Device Name
    SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
    K Number
    K012512
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiant Medical
    Date Received
    August 6, 2001
    Decision Date
    June 11, 2002
    Product Code
    NCX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NCX System, Hypothermia, Intravenous, Cooling

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    Other Clearances by Radiant Medical

    K Number Device Name
    K071358 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K071008 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K063405 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K042388 RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
    K024327 SETPOINT ENDOVASCULAR TEMPERATURE PROBE