510(k) K152069 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Sep 24, 2015 |
| Received | Jul 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152069
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.