510(k) K182064 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
ExpanSure Transseptal Dilation System
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Mar 21, 2019 |
| Received | Aug 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182064
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.