510(k) K230742 ยท PNZ Eustachian Tube Balloon Dilation Device
ACCLARENT AERA Eustachian Tube Dilation System
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Dec 13, 2023 |
| Received | Mar 17, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230742
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.