510(k) K150550 ยท EZL Catheter, Retention Type, Balloon
SilverCoat Silicone Foley Catheter
| Applicant | Covalontechnologies, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Nov 24, 2015 |
| Received | Mar 3, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150550
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.