510(k) K190098 ยท DYB Introducer, Catheter
Endophys Pressure Sensing Sheath
| Applicant | Endophys Holdings, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Mar 7, 2019 |
| Received | Jan 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190098
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.