510(k) K221528 ยท DXF Catheter, Septostomy
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 22, 2022 |
| Received | May 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K221528
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.