510(k) K233647 · DRE Dilator, Vessel, For Percutaneous Catheterization
VersaCross Connect Transseptal Dilator
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Dec 14, 2023 |
| Received | Nov 14, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K233647
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.