510(k) K181088 ยท DYB Introducer, Catheter
TSP Crosser Transseptal Access System
| Applicant | Transseptal Solutions , Ltd., Natanya, IL |
| Decision | Substantially Equivalent, Sep 28, 2018 |
| Received | Apr 25, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181088
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.