Alsius Corp.
Irvine, CA, US
Alsius Corp. appears in FDA device records in Irvine, CA. FDA records list 9 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 6 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Alsius Corp. between 2003 and 2008. The busiest year on record is 2007, with 3. The most recent is 2008, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2007 | 3 |
| 2008 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K081936 | SOLEX CATHETER, MODEL SL2593 | NCX | Substantially Equivalent | |
| K072234 | THERMOGARD XP THERMAL REGULATION SYSTEM | NCX | Substantially Equivalent | |
| K070161 | QUATTRO CATHETER MODEL IC4593 | NCX | Substantially Equivalent | |
| K063829 | THERMOGARD THERMAL REGULATION SYSTEM | NCX | Unknown | |
| K060308 | COOLGARD 3000 | NCX | Unknown | |
| K052443 | ICY CATHETER, MODEL IC-3893A | NCX | Substantially Equivalent | |
| K051912 | COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B | NCX | Unknown | |
| K030421 | ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM | NCX | Substantially Equivalent | |
| K014241 | COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D | NCX | Unknown |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0503-2007 | Alsius Cool Line Catheter, Model CL-2295AE | Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity. | Terminated | ||
| Z-0502-2007 | Alsius Cool Line Catheter, Model CL-2295A | Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity. | Terminated | ||
| Z-0369-06 | Alsius CoolGard Temperature Regulation System | Alsius has found that fluid spills or ingress may result in an alarm condition. The potential health risk involved in this state can be the discontinuance of therapy. | Terminated | ||
| Z-1397-05 | Alsius CoolGard 3000 Temperature Regulation System | Firm wants users to be aware not to leave the units in standby mode for more than an hour in rooms in excess of 75 F due to risk of an alarm mode being generated due to overheating. | Terminated | ||
| Z-0258-05 | Alsius CoolGard 3000 patient temperature regulation system | Product alarms that there may be a power supply interruption. | Terminated | ||
| Z-1159-04 | Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 | Higher than expected rate of pump alarms occur under specific conditions. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain