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

    SETPOINT ENDOVASCULAR TEMPERATURE PROBE

    K Number: K024327 · Decision Mar 25, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    276
    Registration Numbers
    277
    Same Product Code
    889
    Applicant Total
    6
    Review Days
    89

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    Basic Information

    Device Name
    SETPOINT ENDOVASCULAR TEMPERATURE PROBE
    K Number
    K024327
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiant Medical
    Date Received
    December 26, 2002
    Decision Date
    March 25, 2003
    Product Code
    DQY
    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
    DQY Catheter, Percutaneous

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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
    K012512 SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM