510(k) K190688 ยท DYB Introducer, Catheter
VersaCross Steerable Sheath, VersaCross Transseptal Dilator
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Mar 18, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190688
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.