510(k) K033134 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
| Applicant | Ev3, Inc., Plymouth MN, US |
| Decision | Unknown, Nov 17, 2003 |
| Received | Sep 30, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 21mm 80 cm .018'" REF PMB 8-7-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 18mm 80 cm .018" REF PMB 8-7-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 7mm x 14mm 80 cm .018" REF PMB 8-7-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 21mm 80 cm .018" REF PMB 8-6-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 18mm 80 cm .018" REF PMB 8-6-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 6mm x 14mm 80 cm .018" REF PMB 8-6-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 21mm 80 cm .018'" REF PMB 8-5-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 18mm 80 cm .018" REF PMB 8-5-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System, 5mm x 14mm 80 cm .018" REF PMB 8-5-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMB 4-7-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMB 4-7-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMB 4-7-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .014" REF PMB 4-6-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 18 mm 80 cm .014" REF PMB 4-6-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 6mm x 14mm 80 cm .014" REF PMB 4-6-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMB 4-5-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMB 4-5-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Biliary Stent System, Balloon Expandable Stent and Delivery System 5mm x 14 mm 80 cm .014" REF PMB 4-5-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .018" REF PMP 8-7-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .018" REF PMP 8-7-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .018" REF PMP 8-7-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .018" REF PMP 8-6-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm .018" REF PMP8-6-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14 80 cm .018" REF PMP 8-6-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm 0.18" REF PMP 8-5-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .018" REF PMP 8-5-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 14mm 80 cm .018" REF PMP 8-5-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 21mm 80 cm .014" REF PMP4-7-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 18mm 80 cm .014" REF PMP 4-7-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 7mm x 14mm 80 cm .014" REF PMP 4-7-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 21mm 80 cm .014" REF PMP 4-6-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 18mm 80 cm 0.14" REF PMP 4-6-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 6mm x 14mm 80 cm .014" REF PMP 4-6-14-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 21mm 80 cm .014" REF PMP 4-5-21-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery System 5mm x 18mm 80 cm .014" REF PMP 4-5-18-80 Terminated |
FGE | None listed |
| Jul 20, 2004 | ev3, Inc. ParaMount Mini GPS Stent System, Peripheral System, Balloon Expandable Stent and Delivery system 5mm x 14mm 80 cm .014" REF PMP4-5-14-80 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.