NCX — System, Hypothermia, Intravenous, Cooling Class II
FDA product code NCX covers "System, Hypothermia, Intravenous, Cooling", a Class II medical device regulated under 21 CFR 870.5900. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K223746 | zoll circulation | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha | January 13, 2023 |
| K220008 | zoll circulation | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha | June 2, 2022 |
| K213031 | zoll circulation | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha | December 20, 2021 |
| K152946 | seiratherm | TEMPEDY | September 15, 2016 |
| K153162 | novocor medical systems | Hypocore | May 24, 2016 |
| K153226 | zoll circulation | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | March 24, 2016 |
| K150046 | zoll circulation | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravas | October 30, 2015 |
| K141139 | zoll circulation | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | October 3, 2014 |
| K101987 | zoll circulation | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CAT | October 12, 2010 |
| K080908 | innercool therapies, inc.- a delaware corporation | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | October 17, 2008 |
| K081936 | alsius | SOLEX CATHETER, MODEL SL2593 | August 13, 2008 |
| K080899 | medivance | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | August 7, 2008 |
| K072234 | alsius | THERMOGARD XP THERMAL REGULATION SYSTEM | August 23, 2007 |
| K071358 | radiant medical | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | June 1, 2007 |
| K071008 | radiant medical | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | May 9, 2007 |
| K070161 | alsius | QUATTRO CATHETER MODEL IC4593 | February 15, 2007 |
| K063829 | alsius | THERMOGARD THERMAL REGULATION SYSTEM | January 22, 2007 |
| K063405 | radiant medical | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | January 8, 2007 |
| K060308 | alsius | COOLGARD 3000 | April 26, 2006 |
| K052443 | alsius | ICY CATHETER, MODEL IC-3893A | October 17, 2005 |