510(k) K140561 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT)
| Applicant | Xlumena, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Apr 23, 2014 |
| Received | Mar 5, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140561
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.