510(k) K182463 ยท EZL Catheter, Retention Type, Balloon
Silicone Foley Catheter
| Applicant | Biosensors International Pte, Ltd., Singapore, SG |
| Decision | Substantially Equivalent, Nov 6, 2019 |
| Received | Sep 10, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182463
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.