510(k) K212077 ยท EZL Catheter, Retention Type, Balloon
Teleflex Rusch SoftSimplastic Foley Catheters
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Jul 27, 2023 |
| Received | Jul 2, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212077
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.