Company ยท US
Alsius Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2008. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
6recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NCX | System, Hypothermia, Intravenous, Cooling | 15 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 13, 2008 | K081936 | SOLEX CATHETER, MODEL SL2593 Alsius Corp. | NCX |
| Aug 23, 2007 | K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM Alsius Corp. | NCX |
| Feb 15, 2007 | K070161 | QUATTRO CATHETER MODEL IC4593 Alsius Corp. | NCX |
| Jan 22, 2007 | K063829 | THERMOGARD THERMAL REGULATION SYSTEM Alsius Corp. | NCX |
| Apr 26, 2006 | K060308 | COOLGARD 3000 Alsius Corp. | NCX |
| Oct 17, 2005 | K052443 | ICY CATHETER, MODEL IC-3893A Alsius Corp. | NCX |
| Oct 11, 2005 | K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B Alsius Corp. | NCX |
| Oct 23, 2003 | K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM Alsius Corp. | NCX |
| Aug 1, 2003 | K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D Alsius Corp. | NCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2007 | Alsius Corporation Alsius Cool Line Catheter, Model CL-2295AE Terminated |
NCX | K014241 |
| Feb 15, 2007 | Alsius Corporation Alsius Cool Line Catheter, Model CL-2295A Terminated |
NCX | K014241 |
| Jan 10, 2006 | Alsius Corporation Alsius CoolGard Temperature Regulation System Terminated |
NCX | K014241 K030421 |
| Aug 24, 2005 | Alsius Corporation Alsius CoolGard 3000 Temperature Regulation System Terminated |
NCX | K014241 K030421 |
| Nov 25, 2004 | Alsius Corporation Alsius CoolGard 3000 patient temperature regulation system Terminated |
NCX | K014241 K030421 |
| Jul 23, 2004 | Alsius Corporation Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 Terminated |
NCX | K014241 K030421 |