510(k) K161392 ยท KTI Bronchoscope Accessory
Elation Pulmonary Balloon Dilation
| Applicant | Merit Medical Systems, Inc., South Jordan UT, US |
| Decision | Substantially Equivalent, Sep 1, 2016 |
| Received | May 19, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161392
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.