FDA Product Code
FDA Product Code NCX — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.5900
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | Zoll Circulation, Inc. | 2023-01-13 | Special | PDF ↗ |
| 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 | Zoll Circulation, Inc. | 2022-06-02 | Traditional | PDF ↗ |
| 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 | Zoll Circulation, Inc. | 2021-12-20 | Traditional | PDF ↗ |
| K152946 | TEMPEDY | Seiratherm GmbH | 2016-09-15 | Traditional | PDF ↗ |
| K153162 | Hypocore | Novocor Medical Systems, Inc. | 2016-05-24 | Traditional | PDF ↗ |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016-03-24 | Traditional | PDF ↗ |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | Zoll Circulation, Inc. | 2015-10-30 | Traditional | PDF ↗ |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | 2014-10-03 | Traditional | PDF ↗ |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | Zoll Circulation | 2010-10-12 | Traditional | PDF ↗ |
| K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 | Special | PDF ↗ |
| K081936 | SOLEX CATHETER, MODEL SL2593 | Alsius Corp. | 2008-08-13 | Traditional | PDF ↗ |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Medivance, Inc. | 2008-08-07 | Traditional | PDF ↗ |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | 2007-08-23 | Special | PDF ↗ |
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-06-01 | Traditional | PDF ↗ |
| K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-05-09 | Traditional | PDF ↗ |
| K070161 | QUATTRO CATHETER MODEL IC4593 | Alsius Corp. | 2007-02-15 | Traditional | PDF ↗ |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | Alsius Corp. | 2007-01-22 | Special | PDF ↗ |
| K063405 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-01-08 | Special | PDF ↗ |
| K060308 | COOLGARD 3000 | Alsius Corp. | 2006-04-26 | Traditional | PDF ↗ |
| K052443 | ICY CATHETER, MODEL IC-3893A | Alsius Corp. | 2005-10-17 | Traditional | PDF ↗ |
| K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | Alsius Corp. | 2005-10-11 | Traditional | PDF ↗ |
| K033623 | CELSIUS CONTROL SYSTEM | Innercool Therapies, Inc. | 2004-05-21 | Traditional | PDF ↗ |
| K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | Alsius Corp. | 2003-10-23 | Traditional | PDF ↗ |
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | Alsius Corp. | 2003-08-01 | Traditional | PDF ↗ |
| K022366 | CELSIUS CONTROL SYSTEM | Innercool Therapies | 2003-01-27 | Traditional | PDF ↗ |
| K012512 | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM | Radiant Medical | 2002-06-11 | Traditional | PDF ↗ |
Product code NCX · Class II · Cardiovascular. Data: openFDA.