The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Thermogard Xp Thermal Regulation System.
| Device ID | K072234 |
| 510k Number | K072234 |
| Device Name: | THERMOGARD XP THERMAL REGULATION SYSTEM |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ALSIUS CORP. 15770 LAGUNA CANYON RD SUITE 150 Irvine, CA 92618 |
| Contact | Kenneth A Collins |
| Correspondent | Kenneth A Collins ALSIUS CORP. 15770 LAGUNA CANYON RD SUITE 150 Irvine, CA 92618 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-10 |
| Decision Date | 2007-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849111075572 | K072234 | 000 |
| 00849111075794 | K072234 | 000 |
| 00849111075008 | K072234 | 000 |
| 00849111075015 | K072234 | 000 |
| 00849111075022 | K072234 | 000 |
| 00849111075367 | K072234 | 000 |
| 00849111075374 | K072234 | 000 |
| 00849111075558 | K072234 | 000 |
| 00849111075565 | K072234 | 000 |
| 00849111075787 | K072234 | 000 |