510(k) K192034 ยท EZL Catheter, Retention Type, Balloon
HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc
| Applicant | Pathway, LLC, Santee CA, US |
| Decision | Substantially Equivalent, Apr 21, 2020 |
| Received | Jul 30, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192034
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.