Product code NCX— Cardiovascular
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- Classification name
- System, Hypothermia, Intravenous, Cooling
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Total cleared
- 26
- First cleared
- Most recent
Market context for product code NCX
FDA has cleared devices under product code NCX between 2002 and 2023, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2022
- 2021
- 2016
- 2015
- 2014
- 2010
- 2008
- 2007
- 2006
- 2005
- 2004
- 2003
- 2002
Top applicants under product code NCX
Adverse events under product code NCX
product code NCX- Death
- 30
- Malfunction
- 2,302
- Total
- 2,332
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code NCX
- 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
- 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
- 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
- K152946 — TEMPEDY
- K153162 — Hypocore
- K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
- K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
- K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
- K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
- K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM
- K081936 — SOLEX CATHETER, MODEL SL2593
- K080899 — ARCTIC BLAST INTRAVENOUS FLUID CHILLER
- K072234 — THERMOGARD XP THERMAL REGULATION SYSTEM
- K071358 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- K071008 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- K070161 — QUATTRO CATHETER MODEL IC4593
- K063829 — THERMOGARD THERMAL REGULATION SYSTEM
- K063405 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
- K060308 — COOLGARD 3000
- K052443 — ICY CATHETER, MODEL IC-3893A
- K051912 — COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
- K033623 — CELSIUS CONTROL SYSTEM
- K030421 — ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
- K014241 — COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D
- K022366 — CELSIUS CONTROL SYSTEM
- K012512 — SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.