510(k) K193466 ยท DYG Catheter, Flow Directed
Swan-Ganz Catheters
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 16, 2020 |
| Received | Dec 16, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193466
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.