510(k) K140667 ยท EZL Catheter, Retention Type, Balloon
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER
| Applicant | Well Lead Medical Co., Ltd., Guangzhou, CN |
| Decision | Substantially Equivalent, Dec 15, 2014 |
| Received | Mar 18, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140667
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.