510(k) K180620 ยท DYB Introducer, Catheter
Endophys Pressure Sensing Sheath Kit
| Applicant | Endophys Holdings, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Oct 12, 2018 |
| Received | Mar 9, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180620
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.