510(k) K964119 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
| Applicant | Boston Scientific Scimed, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 28, 1997 |
| Received | Oct 15, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964119
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 Terminated |
FGE | None listed |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200 Terminated |
FGE | None listed |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300 Terminated |
FGE | None listed |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400 Terminated |
FGE | None listed |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500 Terminated |
FGE | None listed |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.