510(k) K191190 ยท DYB Introducer, Catheter
Steerable Introducer
| Applicant | Freudenberg Medical, LLC, Jeffersonville IN, US |
| Decision | Substantially Equivalent, Aug 1, 2019 |
| Received | May 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191190
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.