510(k) K173657 ยท EZL Catheter, Retention Type, Balloon
Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 23, 2018 |
| Received | Nov 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173657
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.