510(k) K043481 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO: ZILVER 635 BILIARY STENT
| Applicant | Cook, Inc., Bloomington IN, US |
| Decision | Unknown, Dec 29, 2004 |
| Received | Dec 15, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30
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 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40
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 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60
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 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80
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 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30
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 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40
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 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60
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 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80
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 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20
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 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30
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 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40
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 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80
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 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30
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 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40
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 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60
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 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80
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 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30
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 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40
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 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60
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 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80
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 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80
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 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20
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 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30
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 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40
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 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
| Sep 25, 2018 | Cook Medical Incorporated Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80
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 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80
Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.