510(k) K191546 ยท DYB Introducer, Catheter
Epicardial Access System
| Applicant | Baylis Medical Company, Inc., Mississauga, CA |
| Decision | Substantially Equivalent, Aug 2, 2019 |
| Received | Jun 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191546
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.