510(k) K081936 ยท NCX System, Hypothermia, Intravenous, Cooling
SOLEX CATHETER, MODEL SL2593
| Applicant | Alsius Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 13, 2008 |
| Received | Jul 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081936
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.