Innercool Therapies, Inc., Rapidblue System
FDA 510(k) K080908 · Innercool Therapies, Inc.- A Delaware Corporation
510(k) numberK080908
Submission
- Device name
- Innercool Therapies, Inc., Rapidblue System
- Applicant
- Innercool Therapies, Inc.- A Delaware Corporation
San Diego, CA, US - Received
- April 1, 2008
- Decision date
- October 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K081936 | Solex Catheter, Model SL2593NCX · Traditional | Alsius Corp. | 08/13/2008SE |
Questions and answers
When was Innercool Therapies, Inc., Rapidblue System cleared by the FDA?
Innercool Therapies, Inc., Rapidblue System (K080908) received a 510(k) decision of Substantially Equivalent on October 17, 2008, 199 days after the submission was received.
What is the product code of K080908?
The FDA product code is NCX – System, Hypothermia, Intravenous, Cooling, a Class II (moderate risk) device regulated under 21 CFR 870.5900.