510(k) K062798 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
| Applicant | Cordis Corp., Warren NJ, US |
| Decision | Unknown, Feb 6, 2008 |
| Received | Sep 19, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062798
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.