510(k) K190941 ยท DYB Introducer, Catheter
BioCardia 8.5 F Avance Steerable lntroducer
| Applicant | Biocardia, Inc., San Carlos CA, US |
| Decision | Substantially Equivalent, May 6, 2019 |
| Received | Apr 10, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190941
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.