510(k) K160645 ยท DQE Catheter, Oximeter, Fiber-Optic
PreSep Oligon Oximetry Catheter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 16, 2016 |
| Received | Mar 7, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160645
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.