510(k) K181855 ยท DYB Introducer, Catheter
RadialSeal Introducer Kit
| Applicant | Great Batch Medical, Plymouth MN, US |
| Decision | Substantially Equivalent, Jul 26, 2018 |
| Received | Jul 11, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181855
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.