510(k) K110167 ยท DQE Catheter, Oximeter, Fiber-Optic
PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 18, 2011 |
| Received | Jan 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110167
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.