510(k) K182635 ยท EZL Catheter, Retention Type, Balloon
Signal Catheter
| Applicant | Safe Medical Design, San Francisco CA, US |
| Decision | Substantially Equivalent, Jan 10, 2019 |
| Received | Sep 24, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182635
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.