510(k) K031777 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Unknown, Jul 7, 2003 |
| Received | Jun 10, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031777
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System***Assembled in Mexico Terminated |
FGE | None listed |
| May 10, 2012 | Cordis Corporation Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Biliary System***Assemble Terminated |
FGE | None listed |
| Feb 15, 2012 | Cordis Corporation S.M.A.R.T. CONTROL Transhepatic Biliary Stent. The Self-Expanding Nitinol Biliary Stent is delivered by catheter for the palliation of malignant neoplasms in the biliary tree.
Model numbers are Cxx Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.