The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Thermogard Thermal Regulation System.
| Device ID | K063829 |
| 510k Number | K063829 |
| Device Name: | THERMOGARD THERMAL REGULATION SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618 |
| Contact | Kenneth A Collins |
| Correspondent | Kenneth A Collins ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-01-22 |
| Summary: | summary |