510(k) K032137 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Unknown, Sep 17, 2003 |
| Received | Jul 11, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032137
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Cordis Corporation This medical device is packaged in an inner Tyvek pouch and then in an outer carton. The outer carton is labeled as Cordis PRECISE RX Nitinol Stent Transhepatic Biliary System Cordis a Johnson n Joh Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.