Panels › Cardiovascular › Product code NCX · Class 2
System, Hypothermia, Intravenous, Cooling
Regulation 870.5900
0510(k)s in 12 months (26 all time)
0recalls in 12 months (35 all time)
32recalls that name a 510(k)
Top companies in NCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Zoll Circulation | 7 | 28 |
| Alsius Corp. | 9 | 6 |
| Radiant Medical | 4 | 0 |
| Innercool Therapies | 2 | 0 |
| Innercool Therapies, Inc.- A Delaware Corporation | 1 | 0 |
| Medivance, Inc. | 1 | 0 |
| Novocor Medical Systems, Inc. | 1 | 0 |
| Philips Healthcare | 0 | 1 |
| Seiratherm GmbH | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2023 | K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Jun 2, 2022 | K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Dec 20, 2021 | K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exc Zoll Circulation, Inc. | NCX |
| Sep 15, 2016 | K152946 | TEMPEDY Seiratherm GmbH, DE | NCX |
| May 24, 2016 | K153162 | Hypocore Novocor Medical Systems, Inc. | NCX |
| Mar 24, 2016 | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit Zoll Circulation, Inc. | NCX |
| Oct 30, 2015 | K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro In Zoll Circulation, Inc. | NCX |
| Oct 3, 2014 | K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER Zoll Circulation | NCX |
| Oct 12, 2010 | K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 Zoll Circulation | NCX |
| Oct 17, 2008 | K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM Innercool Therapies, Inc.- A Delaware Corporation | NCX |
| Aug 13, 2008 | K081936 | SOLEX CATHETER, MODEL SL2593 Alsius Corp. | NCX |
| Aug 7, 2008 | K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER Medivance, Inc. | NCX |
| Aug 23, 2007 | K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM Alsius Corp. | NCX |
| Jun 1, 2007 | K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM Radiant Medical | NCX |
| May 9, 2007 | K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM Radiant Medical | NCX |
| Feb 15, 2007 | K070161 | QUATTRO CATHETER MODEL IC4593 Alsius Corp. | NCX |
| Jan 22, 2007 | K063829 | THERMOGARD THERMAL REGULATION SYSTEM Alsius Corp. | NCX |
| Jan 8, 2007 | K063405 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM Radiant Medical | NCX |
| Apr 26, 2006 | K060308 | COOLGARD 3000 Alsius Corp. | NCX |
| Oct 17, 2005 | K052443 | ICY CATHETER, MODEL IC-3893A Alsius Corp. | NCX |
| Oct 11, 2005 | K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B Alsius Corp. | NCX |
| May 21, 2004 | K033623 | CELSIUS CONTROL SYSTEM Innercool Therapies, Inc. | NCX |
| Oct 23, 2003 | K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM Alsius Corp. | NCX |
| Aug 1, 2003 | K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D Alsius Corp. | NCX |
| Jan 27, 2003 | K022366 | CELSIUS CONTROL SYSTEM Innercool Therapies | NCX |
| Jun 11, 2002 | K012512 | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM Radiant Medical | NCX |
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