510(k) K190369 ยท DYB Introducer, Catheter
M-Y Sheath
| Applicant | Ram Medical Innovations, Inc., Springfield OH, US |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Feb 15, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190369
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.