510(k) K111315 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MULTIPURPOSE DRAINAGE CATHETER
| Applicant | Navilyst Medical, Inc., Marlborough MA, US |
| Decision | Substantially Equivalent, Jun 8, 2011 |
| Received | May 10, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111315
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.