510(k) K212151 ยท EZL Catheter, Retention Type, Balloon
FLUME catheter
| Applicant | The Flume Catheter Company, Ltd., Frensham, GB |
| Decision | Substantially Equivalent, Nov 3, 2021 |
| Received | Jul 9, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212151
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.