510(k) K051912 ยท NCX System, Hypothermia, Intravenous, Cooling
COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B
| Applicant | Alsius Corp., Irvine CA, US |
| Decision | Unknown, Oct 11, 2005 |
| Received | Jul 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051912
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.