510(k) K180275 ยท KRA Catheter, Continuous Flush
VAMP Optima closed blood sampling system
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Oct 24, 2018 |
| Received | Jan 31, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180275
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.