510(k) K203459 ยท DYB Introducer, Catheter
SafeCross Transseptal Puncture and Introducer (TSP/I) System
| Applicant | East End Medical I, LLC, Sunrise FL, US |
| Decision | Substantially Equivalent, Jul 6, 2021 |
| Received | Nov 24, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203459
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.