510(k) K252537 ยท EZL Catheter, Retention Type, Balloon
Rusch SoftSimplastic Foley Catheters
| Applicant | Teleflex Medical Sdn. Bhd., Kamunting, MY |
| Decision | Substantially Equivalent, Jan 20, 2026 |
| Received | Aug 12, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K252537
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.