Alsius Corp.
Medical device manufacturer in Irvine, CA.
9510(k) clearances
0PMA approvals
2recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K081936 | Solex Catheter, Model SL2593NCX · Traditional | 08/13/2008SE |
| K072234 | Thermogard XP Thermal Regulation SystemNCX · Special | 08/23/2007SE |
| K070161 | Quattro Catheter Model IC4593NCX · Traditional | 02/15/2007SE |
| K063829 | Thermogard Thermal Regulation SystemNCX · Special | 01/22/2007SESU |
| K060308 | Coolgard 3000NCX · Traditional | 04/26/2006SESU |
| K052443 | Icy Catheter, Model IC-3893ANCX · Traditional | 10/17/2005SE |
| K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…NCX · Traditional | 10/11/2005SESU |
| K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemNCX · Traditional | 10/23/2003SE |
| K014241 | Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500DNCX · Traditional | 08/01/2003SESU |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0503-2007 | Alsius Cool Line Catheter, Model CL-2295AETesting by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a… | 01/01/2007Terminated |
| Z-0502-2007 | Alsius Cool Line Catheter, Model CL-2295ATesting by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a… | 01/01/2007Terminated |