510(k) K172128 · PIE Esophageal Dilator With Balloon And Electrode Sensors
EsoFLIP® ES-310 Balloon Catheter
| Applicant | Crospon, Ltd., Galway, IE |
| Decision | Substantially Equivalent, Nov 22, 2017 |
| Received | Jul 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172128
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.