510(k) K180054 ยท DQO Catheter, Intravascular, Diagnostic
Royal Flush Plus High-Flow Catheter
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 5, 2018 |
| Received | Jan 8, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180054
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.