510(k) K201288 ยท DRE Dilator, Vessel, For Percutaneous Catheterization
ExpanSure Large Access Transseptal Dilator
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jun 12, 2020 |
| Received | May 14, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201288
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.