510(k) K093893 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
| Applicant | Idev Technologies, Inc., Webster TX, US |
| Decision | Unknown, Oct 5, 2010 |
| Received | Dec 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093893
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2012 | Idev Technologies, Inc. SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System.
Intended to be used for palliative treatment of biliary strictures produced by malignant neoplasms. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.