510(k) K222117 ยท DYG Catheter, Flow Directed
Swang-Ganz IQ pulmonary artery catheter
| Applicant | Edwards Lifesiences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Dec 9, 2022 |
| Received | Jul 18, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222117
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.