NCX · System, Hypothermia, Intravenous, Cooling
Cardiovascular · 21 CFR 870.5900 · Class 2
Overview
| Product Code | NCX |
|---|---|
| Device Name | System, Hypothermia, Intravenous, Cooling |
| Regulation | 21 CFR 870.5900 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 26)
Showing 20 most recent of 26 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| 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. | Jan 13, 2023 | SESU |
| 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. | Jun 2, 2022 | SESU |
| 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. | Dec 20, 2021 | SESU |
| K152946 | TEMPEDY | Seiratherm GmbH | Sep 15, 2016 | SESE |
| K153162 | Hypocore | Novocor Medical Systems, Inc. | May 24, 2016 | SESE |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | Zoll Circulation, Inc. | Mar 24, 2016 | SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter | Zoll Circulation, Inc. | Oct 30, 2015 | SESU |
| K141139 | SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER | Zoll Circulation | Oct 3, 2014 | SESE |
| K101987 | COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 | Zoll Circulation | Oct 12, 2010 | SESU |
| K080908 | INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM | Innercool Therapies, Inc.- A Delaware Corporation | Oct 17, 2008 | SESE |
| K081936 | SOLEX CATHETER, MODEL SL2593 | Alsius Corp. | Aug 13, 2008 | SESE |
| K080899 | ARCTIC BLAST INTRAVENOUS FLUID CHILLER | Medivance, Inc. | Aug 7, 2008 | SESE |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | Alsius Corp. | Aug 23, 2007 | SESE |
| K071358 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | Jun 1, 2007 | SESE |
| K071008 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | May 9, 2007 | SESU |
| K070161 | QUATTRO CATHETER MODEL IC4593 | Alsius Corp. | Feb 15, 2007 | SESE |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | Alsius Corp. | Jan 22, 2007 | SESU |
| K063405 | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM | Radiant Medical | Jan 8, 2007 | SESE |
| K060308 | COOLGARD 3000 | Alsius Corp. | Apr 26, 2006 | SESU |
| K052443 | ICY CATHETER, MODEL IC-3893A | Alsius Corp. | Oct 17, 2005 | SESE |
Top Applicants
- Alsius Corp. — 9 clearances
- Zoll Circulation, Inc. — 5 clearances
- Radiant Medical — 4 clearances
- Zoll Circulation — 2 clearances
- Innercool Therapies — 1 clearance
