510(k) K180418 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Reliant(TM) Multistage Dilatation Balloon Catheter
| Applicant | Micro-Tech (Nanjing) Co., Ltd., Nanjing, CN |
| Decision | Substantially Equivalent, Oct 15, 2018 |
| Received | Feb 15, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180418
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.