510(k) K230065 · PNZ Eustachian Tube Balloon Dilation Device
VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav Balloon Dilation System, VenSure ET Balloon Dilation System
| Applicant | Fiagon GmbH, Hennigsdorf, DE |
| Decision | Substantially Equivalent, May 26, 2023 |
| Received | Jan 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230065
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.