Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500D
FDA 510(k) K014241 · Alsius Corp.
510(k) numberK014241
Submission
- Device name
- Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500D
- Applicant
- Alsius Corp.
Irvine, CA, US - Received
- December 26, 2001
- Decision date
- August 1, 2003
- Decision
- Unknown (SESU)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NCX – System, Hypothermia, Intravenous, Cooling
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5900
- Specialty
- Cardiovascular
Other 510(k)s with product code NCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | Zoll Circulation, Inc. | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 12/20/2021SESU |
| K152946 | TempedyNCX · Traditional | Seiratherm GmbH | 09/15/2016SE |
| K153162 | HypocoreNCX · Traditional | Novocor Medical Systems, Inc. | 05/24/2016SE |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | Zoll Circulation, Inc. | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | Zoll Circulation, Inc. | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | Zoll Circulation | 10/03/2014SE |
| K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…NCX · Traditional | Zoll Circulation | 10/12/2010SESU |
| K080908 | Innercool Therapies, Inc., Rapidblue SystemNCX · Special | Innercool Therapies, Inc.- A Delaware Corporation | 10/17/2008SE |
More from Innercool Therapies, Inc.- A Delaware Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K081936 | Solex Catheter, Model SL2593NCX · Traditional | 08/13/2008SE |
| K072234 | Thermogard XP Thermal Regulation SystemNCX · Special | 08/23/2007SE |
| K070161 | Quattro Catheter Model IC4593NCX · Traditional | 02/15/2007SE |
| K063829 | Thermogard Thermal Regulation SystemNCX · Special | 01/22/2007SESU |
| K060308 | Coolgard 3000NCX · Traditional | 04/26/2006SESU |
| K052443 | Icy Catheter, Model IC-3893ANCX · Traditional | 10/17/2005SE |
| K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…NCX · Traditional | 10/11/2005SESU |
| K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemNCX · Traditional | 10/23/2003SE |
Questions and answers
When was Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500D cleared by the FDA?
Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500D (K014241) received a 510(k) decision of Unknown on August 1, 2003, 583 days after the submission was received.
What is the product code of K014241?
The FDA product code is NCX – System, Hypothermia, Intravenous, Cooling, a Class II (moderate risk) device regulated under 21 CFR 870.5900.