510(k) K162989 ยท EZL Catheter, Retention Type, Balloon
Rusch Simplastic Foley Catheters
| Applicant | Teleflexmedical, Inc., Morrisville NC, US |
| Decision | Substantially Equivalent, Feb 24, 2017 |
| Received | Oct 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162989
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.