The following data is part of a premarket notification filed by Radiant Medical with the FDA for Setpoint Endovascular Temperature Management System.
| Device ID | K012512 |
| 510k Number | K012512 |
| Device Name: | SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Andrew Cleeland |
| Correspondent | Andrew Cleeland RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-06 |
| Decision Date | 2002-06-11 |
| Summary: | summary |