510(k) K181616 ยท EZL Catheter, Retention Type, Balloon
PSM 3-Way Silicone Foley Catheter
| Applicant | Pathway, LLC, Santee CA, US |
| Decision | Substantially Equivalent, Sep 21, 2018 |
| Received | Jun 19, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181616
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.