510(k) K173399 ยท DYB Introducer, Catheter
Endophys Pressure Sensing Sheath Kit- 8F
| Applicant | Endophys Holdings, LLC, Dallas TX, US |
| Decision | Substantially Equivalent, Nov 30, 2017 |
| Received | Oct 31, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173399
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.