510(k) K010411 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
| Applicant | Cordis Corp., Warren NJ, US |
| Decision | Unknown, Aug 27, 2001 |
| Received | Feb 12, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K010411
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | Cordis Corporation This device is labeled as Sterile and is packaged in a Tyvek pouch with the following labeling: PALMAZ Genesis TRANSHEPATIC BILIARY STENT on Aviator RX Delivery System REF Cat. No. Cordis ENDOVASCULA Terminated |
MAF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.