510(k) K162427 ยท DYB Introducer, Catheter
Vado Bi-Directional Steerable Sheath
| Applicant | Kalila Medical, Inc., Campbell CA, US |
| Decision | Substantially Equivalent, Jan 27, 2017 |
| Received | Aug 30, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2017 | Kalila Medical Vado Bi-Directional Steerable Sheath 8.8F, REF SS8FMB74, packaged in a lidded tray that is within a pouch which is inserted into a shelf carton, Sterile, Rx. The firm name on the label is Kalila Medi Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.