510(k) K231101 ยท EZL Catheter, Retention Type, Balloon
Flume Catheter
| Applicant | Flume Catheter Company, Ltd., Farnham, GB |
| Decision | Substantially Equivalent, Jun 29, 2023 |
| Received | Apr 18, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K231101
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.