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

    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

    K Number: K063405 · Decision Jan 8, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    60

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K Number
    K063405
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radiant Medical
    Date Received
    November 9, 2006
    Decision Date
    January 8, 2007
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (NCX), ordered by most recent decision date.

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TEMPEDY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hypocore

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Radiant Medical

    K Number Device Name
    K071358 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K071008 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K042388 RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE
    K024327 SETPOINT ENDOVASCULAR TEMPERATURE PROBE
    K012512 SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM