510(k) K210841 ยท PNZ Eustachian Tube Balloon Dilation Device
NuVent Eustachian Tube Dilation Balloon
| Applicant | Medtronic Xomed, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, Aug 16, 2021 |
| Received | Mar 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210841
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.