Product code NCX
- Device name
- System, Hypothermia, Intravenous, Cooling
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.5900
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 ... | Zoll Circulation, Inc. | 2022-06-02 |
| 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 |
| K152946 | TEMPEDY | Seiratherm GmbH | 2016-09-15 |
| K153162 | Hypocore | Novocor Medical Systems, Inc. | 2016-05-24 |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | 2016-03-24 |
| 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 |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | 2014-10-03 |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | Zoll Circulation | 2010-10-12 |
| K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | Innercool Therapies, Inc.- A Delaware Corporation | 2008-10-17 |
| K081936 | SOLEX CATHETER, MODEL SL2593 | Alsius Corp. | 2008-08-13 |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Medivance, Inc. | 2008-08-07 |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | 2007-08-23 |
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-06-01 |
| K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-05-09 |
| K070161 | QUATTRO CATHETER MODEL IC4593 | Alsius Corp. | 2007-02-15 |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | Alsius Corp. | 2007-01-22 |
| K063405 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | 2007-01-08 |
| K060308 | COOLGARD 3000 | Alsius Corp. | 2006-04-26 |
| K052443 | ICY CATHETER, MODEL IC-3893A | Alsius Corp. | 2005-10-17 |
| 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 |
| K033623 | CELSIUS CONTROL SYSTEM | Innercool Therapies, Inc. | 2004-05-21 |
| K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | Alsius Corp. | 2003-10-23 |
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | Alsius Corp. | 2003-08-01 |
| K022366 | CELSIUS CONTROL SYSTEM | Innercool Therapies | 2003-01-27 |
| K012512 | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM | Radiant Medical | 2002-06-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00849111075794 | Thermogard XP, Lang set C, Rohs, Refurb | Zoll Circulation, Inc. | 2023-01-17 |
| 00849111075787 | Thermogard XP, Lang set C, Rohs | Zoll Circulation, Inc. | 2023-01-17 |
| 00849111075800 | Thermogard HQTM Console | Zoll Circulation, Inc. | 2022-06-27 |
| 00849111075862 | Thermogard HQTM Start-Up Kit | Zoll Circulation, Inc. | 2022-06-27 |
| 00849111075879 | Thermogard HQTM Start-Up Kit EX | Zoll Circulation, Inc. | 2022-06-27 |
| 00849111050043 | ICY-3, Japan, Final Packaged Kit (Applause) | Zoll Circulation, Inc. | 2016-10-10 |
| 00849111050050 | Quattro, Japan, Final Packaged Kit (Applause) | Zoll Circulation, Inc. | 2016-10-10 |
| 00849111050081 | Start-Up Kit Japan | Zoll Circulation, Inc. | 2016-10-10 |
| 00849111075176 | Cool Line® Intravascular Heat Exchange Catheter Kit Japan, Final Pkged Kit Ne | Zoll Circulation, Inc. | 2016-10-10 |
| 00849111075190 | Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin | Zoll Circulation, Inc. | 2015-07-30 |
| 00849111075183 | Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom Luer | Zoll Circulation, Inc. | 2015-07-30 |
| 00849111075107 | ICY® Intravascular Heat Exchange Catheter Kit (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111050029 | Start-Up Kit | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111050074 | Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075008 | Thermogard XP® | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075169 | SOLEX® Intravascular Heat Exchange Catheter EU Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075152 | SOLEX® Intravascular Heat Exchange Catheter US Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075145 | QUATTRO® Intravascular Heat Exchange Catheter Kit Appluase (Heparin), Non Lidoca | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075138 | QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075121 | QUATTRO® Intravascular Heat Exchange Catheter Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075114 | QUATTRO® Intravascular Heat Exchange Catheter Kit Surmodics Non-Heparin | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075015 | Thermogard XP® | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075091 | ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin), Non Lidocaine | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075084 | ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075077 | ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075060 | Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075053 | Cool Line® Intravascular Heat Exchange Catheter Kit US (Surmodics Non-Lidocaine) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075046 | Cool Line® Intravascular Heat Exchange Catheter Kit Applause (Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075039 | Cool Line® Intravascular Heat Exchange Catheter Kit (Non Heparin) | Zoll Circulation, Inc. | 2015-03-31 |
| 00849111075022 | Thermogard XP® | Zoll Circulation, Inc. | 2015-03-31 |