510(k) K173533 ยท EZL Catheter, Retention Type, Balloon
Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
| Applicant | Poiesis Medical, LLC, Jupiter FL, US |
| Decision | Substantially Equivalent, Mar 29, 2018 |
| Received | Nov 15, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173533
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.