Setpoint Endovascular Temperature Probe
FDA 510(k) K024327 · Radiant Medical
510(k) numberK024327
Submission
- Device name
- Setpoint Endovascular Temperature Probe
- Applicant
- Radiant Medical
Redwood City, CA, US - Received
- December 26, 2002
- Decision date
- March 25, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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More from Abbott Medical
| 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 |
| K012512 | Setpoint Endovascular Temperature Management SystemNCX · Traditional | 06/11/2002SE |
Questions and answers
When was Setpoint Endovascular Temperature Probe cleared by the FDA?
Setpoint Endovascular Temperature Probe (K024327) received a 510(k) decision of Substantially Equivalent on March 25, 2003, 89 days after the submission was received.
What is the product code of K024327?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.