510(k) K213434 ยท KTI Bronchoscope Accessory
Elation Pulmonary Balloon Dilation Catheter
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Mar 8, 2022 |
| Received | Oct 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213434
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.