510(k) K030421 ยท NCX System, Hypothermia, Intravenous, Cooling
ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM
| Applicant | Alsius Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 23, 2003 |
| Received | Feb 10, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030421
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2006 | Alsius Corporation Alsius CoolGard Temperature Regulation System Terminated |
NCX | None listed |
| Aug 24, 2005 | Alsius Corporation Alsius CoolGard 3000 Temperature Regulation System Terminated |
NCX | None listed |
| Nov 25, 2004 | Alsius Corporation Alsius CoolGard 3000 patient temperature regulation system Terminated |
NCX | None listed |
| Jul 23, 2004 | Alsius Corporation Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 Terminated |
NCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.