Reprieve Endovascular Temperature Therapy System
FDA 510(k) K071358 · Radiant Medical
510(k) numberK071358
Submission
- Device name
- Reprieve Endovascular Temperature Therapy System
- Applicant
- Radiant Medical
Redwood City, CA, US - Received
- May 15, 2007
- Decision date
- June 1, 2007
- 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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| 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 |
|---|---|---|
| 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 |
| K012512 | Setpoint Endovascular Temperature Management SystemNCX · Traditional | 06/11/2002SE |
Questions and answers
When was Reprieve Endovascular Temperature Therapy System cleared by the FDA?
Reprieve Endovascular Temperature Therapy System (K071358) received a 510(k) decision of Substantially Equivalent on June 1, 2007, 17 days after the submission was received.
What is the product code of K071358?
The FDA product code is NCX – System, Hypothermia, Intravenous, Cooling, a Class II (moderate risk) device regulated under 21 CFR 870.5900.