510(k) K023217 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Unknown, Oct 25, 2002 |
| Received | Sep 26, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K023217
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 2, 2003 | Cordis Corporation The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers.
Product is packed in a Tyvek pouch and further packed into a sh Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.