510(k) K202134 ยท EZL Catheter, Retention Type, Balloon
Well Lead All Silicone Foley Catheter with Temperature Sensor
| Applicant | Well Lead Medical Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Apr 8, 2021 |
| Received | Jul 31, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K202134
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.