The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Solex Catheter, Model Sl2593.
| Device ID | K081936 |
| 510k Number | K081936 |
| Device Name: | SOLEX CATHETER, MODEL SL2593 |
| Classification | System, Hypothermia, Intravenous, Cooling |
| Applicant | ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618 |
| Contact | John Riolo |
| Correspondent | John Riolo ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine, CA 92618 |
| Product Code | NCX |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-07 |
| Decision Date | 2008-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849111075541 | K081936 | 000 |
| 00849111075312 | K081936 | 000 |
| 00849111075305 | K081936 | 000 |
| 00849111075169 | K081936 | 000 |
| 00849111075152 | K081936 | 000 |