510(k) K050698 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO:ZILVER 518 BILIARY STENT
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Substantially Equivalent, Mar 30, 2005 |
| Received | Mar 17, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050698
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.