FDA 510(k) Applications for Medical Device Product Code "NCX"
(System, Hypothermia, Intravenous, Cooling)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K030421 | ALSIUS CORP. | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | 10/23/2003 |
| K051912 | ALSIUS CORP. | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | 10/11/2005 |
| K060308 | ALSIUS CORP. | COOLGARD 3000 | 04/26/2006 |
| K014241 | ALSIUS CORP. | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | 08/01/2003 |
| K052443 | ALSIUS CORP. | ICY CATHETER, MODEL IC-3893A | 10/17/2005 |
| K070161 | ALSIUS CORP. | QUATTRO CATHETER MODEL IC4593 | 02/15/2007 |
| K081936 | ALSIUS CORP. | SOLEX CATHETER, MODEL SL2593 | 08/13/2008 |
| K063829 | ALSIUS CORP. | THERMOGARD THERMAL REGULATION SYSTEM | 01/22/2007 |
| K072234 | ALSIUS CORP. | THERMOGARD XP THERMAL REGULATION SYSTEM | 08/23/2007 |
| K022366 | INNERCOOL THERAPIES | CELSIUS CONTROL SYSTEM | 01/27/2003 |
| K033623 | INNERCOOL THERAPIES, INC. | CELSIUS CONTROL SYSTEM | 05/21/2004 |
| K080908 | INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | 10/17/2008 |
| K080899 | MEDIVANCE, INC. | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | 08/07/2008 |
| K153162 | NOVOCOR MEDICAL SYSTEMS, INC | Hypocore | 05/24/2016 |
| K063405 | RADIANT MEDICAL | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | 01/08/2007 |
| K071008 | RADIANT MEDICAL | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | 05/09/2007 |
| K071358 | RADIANT MEDICAL | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | 06/01/2007 |
| K012512 | RADIANT MEDICAL | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM | 06/11/2002 |
| K152946 | SEIRATHERM GMBH | TEMPEDY | 09/15/2016 |
| K101987 | ZOLL CIRCULATION | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | 10/12/2010 |
| K141139 | ZOLL CIRCULATION | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | 10/03/2014 |
| K220008 | ZOLL Circulation, Inc | 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 | 06/02/2022 |
| K213031 | Zoll Circulation, Inc. | 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 | 12/20/2021 |
| K223746 | Zoll Circulation, Inc. | 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 | 01/13/2023 |
| K153226 | ZOLL CIRCULATION, INC. | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | 03/24/2016 |
| K150046 | Zoll Circulation, Inc. | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | 10/30/2015 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
