510(k) K181346 ยท EZL Catheter, Retention Type, Balloon
CystoSure Plus Catheter
| Applicant | Emmy Medical, LLC, Holliston MA, US |
| Decision | Substantially Equivalent, Aug 6, 2018 |
| Received | May 21, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181346
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.