510(k) K231227 ยท DYB Introducer, Catheter
SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Dec 20, 2023 |
| Received | Apr 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231227
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.