The following data is part of a premarket notification filed by Radiant Medical with the FDA for Reprieve Endovascular Temperature Therapy System.
| Device ID | K063405 |
| 510k Number | K063405 |
| Device Name: | REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Scott A Wilson |
| Correspondent | Scott A Wilson RADIANT MEDICAL 250 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-09 |
| Decision Date | 2007-01-08 |
| Summary: | summary |