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NCX — System, Hypothermia, Intravenous, Cooling Class II

FDA Device Classification

Classification Details

Product Code
NCX
Device Class
Class II
Regulation Number
870.5900
Submission Type
Review Panel
NE
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K223746zoll circulationSolex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat ExchaJanuary 13, 2023
K220008zoll circulationSolex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat ExchaJune 2, 2022
K213031zoll circulationSolex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat ExchaDecember 20, 2021
K152946seirathermTEMPEDYSeptember 15, 2016
K153162novocor medical systemsHypocoreMay 24, 2016
K153226zoll circulationSolex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitMarch 24, 2016
K150046zoll circulationStart-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY IntravasOctober 30, 2015
K141139zoll circulationSOLEX INTRAVASCULAR HEAT EXCHANGE CATHETEROctober 3, 2014
K101987zoll circulationCOOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATOctober 12, 2010
K080908innercool therapies, inc.- a delaware corporationINNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEMOctober 17, 2008
K081936alsiusSOLEX CATHETER, MODEL SL2593August 13, 2008
K080899medivanceARCTIC BLAST INTRAVENOUS FLUID CHILLERAugust 7, 2008
K072234alsiusTHERMOGARD XP THERMAL REGULATION SYSTEMAugust 23, 2007
K071358radiant medicalREPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMJune 1, 2007
K071008radiant medicalREPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMMay 9, 2007
K070161alsiusQUATTRO CATHETER MODEL IC4593February 15, 2007
K063829alsiusTHERMOGARD THERMAL REGULATION SYSTEMJanuary 22, 2007
K063405radiant medicalREPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMJanuary 8, 2007
K060308alsiusCOOLGARD 3000April 26, 2006
K052443alsiusICY CATHETER, MODEL IC-3893AOctober 17, 2005