BEUDAMED
    Product Code: NCX FDA class 2 21 CFR 870.5900

    System, Hypothermia, Intravenous, Cooling

    Cardiovascular

    The System, Hypothermia, Intravenous, Cooling (product code NCX) is a cardiovascular device that delivers cooled saline or fluid intravenously to induce systemic hypothermia, typically used in cardiac arrest resuscitation or neuroprotection protocols. It is an FDA Class 2 device within the Cardiovascular specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant but is associated with critical care applications.

    View on FDA
    510(k)s
    26
    FEI Numbers
    4
    Registration Numbers
    4
    Unique Applicants
    10
    Years Active
    21

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    Basic Information

    Product Code
    NCX
    Device Class
    FDA class 2
    Regulation Number
    870.5900
    Medical Specialty
    Cardiovascular
    Review Panel
    NE
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 26 510(k) clearances via K numbers.

    K Number Device Name
    K223746 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
    K220008 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
    K213031 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
    K152946 TEMPEDY
    K153162 Hypocore
    K153226 Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
    K150046 Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
    K141139 SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
    K101987 COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
    K080908 INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
    K081936 SOLEX CATHETER, MODEL SL2593
    K080899 ARCTIC BLAST INTRAVENOUS FLUID CHILLER
    K072234 THERMOGARD XP THERMAL REGULATION SYSTEM
    K071358 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K071008 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K070161 QUATTRO CATHETER MODEL IC4593
    K063829 THERMOGARD THERMAL REGULATION SYSTEM
    K063405 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
    K060308 COOLGARD 3000
    K052443 ICY CATHETER, MODEL IC-3893A
    K051912 COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
    K033623 CELSIUS CONTROL SYSTEM
    K030421 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
    K014241 COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
    K022366 CELSIUS CONTROL SYSTEM
    K012512 SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.