510(k) K171761 ยท PNZ Eustachian Tube Balloon Dilation Device
ACCLARENT AERA Eustachian Tube Balloon Dilation System
| Applicant | Acclarent, Inc., Irvin CA, US |
| Decision | Substantially Equivalent, Jan 16, 2018 |
| Received | Jun 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171761
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.