510(k) K071358 ยท NCX System, Hypothermia, Intravenous, Cooling
REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM
| Applicant | Radiant Medical, Redwood City CA, US |
| Decision | Substantially Equivalent, Jun 1, 2007 |
| Received | May 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071358
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.