510(k) K033314 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Nov 21, 2003 |
| Received | Oct 15, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033314
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Biliary Stent System, Rx Only, and SERB65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | None listed |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Biliary Stent System, Rx Only, and SERB65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms in th Terminated |
FGE | None listed |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 6mm x 80mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-06-80-120.
In the US, the intended as a palliative treatment of malignant neoplasms Terminated |
FGE | None listed |
| Sep 8, 2009 | Ev3, Inc. ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120.
In the US, the intended as a palliative treatment of malignant neoplasms i Terminated |
FGE | None listed |
| Feb 1, 2007 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. Terminated |
FGE | None listed |
| Jun 25, 2005 | Ev3 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-09-60-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Terminated |
FGE | None listed |
| Jun 25, 2005 | Ev3 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-08-20-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Terminated |
FGE | None listed |
| Jun 25, 2005 | Ev3 ev3 Protege GPS Self-Expanding Nitinol Stent and Delivery Technology (Biliary System). Model No. SERB65-10-30-120 ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. Sterile EO. Single Use. Terminated |
FGE | None listed |
| Oct 5, 2004 | Ev3 Biliary Stent System (6Fr 9mm x 30mm). Terminated |
FGE | None listed |
| Aug 7, 2004 | Ev3 Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SER6-10-30-135 (.018) (Biliary) Terminated |
FGE | None listed |
| Aug 7, 2004 | Ev3 Protege GPS Biliary System (6Fr 10mm x 30mm) - Product number SERB65-10-30-120 (.035) (Biliary) Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.