The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Cool Line Catheter Kit, Models Cl-2085b, Cl-2295a; Icy Catheter Kit, Model Ic-3585a; Fortius Catheter Kit, Mod. Fr-5093b.
| Device ID | K051912 |
| 510k Number | K051912 |
| Device Name: | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-14 |
| Decision Date | 2005-10-11 |
| Summary: | summary |