510(k) K213582 ยท DYB Introducer, Catheter
Epicardial Access System
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Jun 30, 2022 |
| Received | Nov 12, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K213582
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.