510(k) K043243 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PRIMUS STENT AND DELIVERY SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Dec 9, 2004 |
| Received | Nov 23, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K043243
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2008 | Ev3, Inc Ev3 Primus GPS Biliary Stent System
8 mm, 37 mm, B7, .40 mm, 5Fr,
REF BXB35-08-37-75
Use before 2009-02
Sterile EO
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
Intended as a palliative treatm Terminated |
FGE | None listed |
| May 31, 2006 | Ev3, Inc ev3 Primus GPS Biliary Stent System. Balloon Expandable Stent and Delivery System. The stent is made from a 316L stainless steel tube cut into an open lattice design. It is mounted onto a non-compl Terminated |
FGE | None listed |
| Jan 25, 2006 | Ev3, Inc Primus Biliary Stent and Delivery System. Balloon Expandable Stent and Delivery System. Rx only. Model BXB35-07-27-75 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.