510(k) K172807 ยท EZL Catheter, Retention Type, Balloon
Silicone Foley Catheter for single use
| Applicant | Changzhou Rongxin Medicine Minimal Invasion Technology, Jintan City, CN |
| Decision | Substantially Equivalent, Jun 4, 2018 |
| Received | Sep 18, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172807
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.