510(k) K070161 ยท NCX System, Hypothermia, Intravenous, Cooling
QUATTRO CATHETER MODEL IC4593
| Applicant | Alsius Corp., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 15, 2007 |
| Received | Jan 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070161
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.