510(k) K161770 ยท EZL Catheter, Retention Type, Balloon
Rusch Silicone Foley Catheter
| Applicant | Teleflexmedical, Inc., Durham NC, US |
| Decision | Substantially Equivalent, May 5, 2017 |
| Received | Jun 28, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161770
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.