Setpoint Endovascular Temperature Management System
FDA 510(k) K012512 · Radiant Medical
510(k) numberK012512
Submission
- Device name
- Setpoint Endovascular Temperature Management System
- Applicant
- Radiant Medical
Redwood City, CA, US - Received
- August 6, 2001
- Decision date
- June 11, 2002
- Decision
- Substantially Equivalent (SESE)
- 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
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| 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 |
|---|---|---|
| K071358 | Reprieve Endovascular Temperature Therapy SystemNCX · Traditional | 06/01/2007SE |
| K071008 | Reprieve Endovascular Temperature Therapy SystemNCX · Traditional | 05/09/2007SESU |
| K063405 | Reprieve Endovascular Temperature Therapy SystemNCX · Special | 01/08/2007SE |
| K042388 | Radiant Medical Endocatheter Temperature ProbeDQY · Traditional | 10/28/2004SE |
| K024327 | Setpoint Endovascular Temperature ProbeDQY · Traditional | 03/25/2003SE |
Questions and answers
When was Setpoint Endovascular Temperature Management System cleared by the FDA?
Setpoint Endovascular Temperature Management System (K012512) received a 510(k) decision of Substantially Equivalent on June 11, 2002, 309 days after the submission was received.
What is the product code of K012512?
The FDA product code is NCX – System, Hypothermia, Intravenous, Cooling, a Class II (moderate risk) device regulated under 21 CFR 870.5900.