Panels › Gastroenterology, Urology › Product code FGE · Class 2
Stents, Drains And Dilators For The Biliary Ducts
Regulation 876.5010
10510(k)s in 12 months (478 all time)
12recalls in 12 months (452 all time)
439recalls that name a 510(k)
Top companies in FGE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific | 56 | 81 |
| Ev3 Corporation | 12 | 71 |
| Bard Peripheral Vascular, Inc. | 2 | 69 |
| Edwards Lifesciences, LLC | 7 | 52 |
| Cordis Corp. | 38 | 14 |
| Cook Medical Incorporated | 0 | 39 |
| Cook Incorporated | 22 | 13 |
| Wilson-Cook Medical, Inc. | 20 | 15 |
| Hobbs Medical, Inc. | 3 | 21 |
| Guidant Corp. | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-26, ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-001.
ev3 IntraStent LD Max Large Diameter Periphera Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Max Large Diameter Biliary Stent, Model Number: S18-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2319-000.
ev3 IntraStent LD Max Large Diameter Peripher Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-002.
ev3 IntraStent LD Mega Large Diameter Periph Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-001.
ev3 IntraStent LD Mega Large Diameter Perip Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD Mega Large Diameter Biliary Stent, Model Number: S17-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-2313-000
ev3 IntraStent LD Mega Large Diameter Peri Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut Large Diameter Biliary Stent, Model Number: S15-36,
ev3, 4600 Nathan lane North, Plymouth, MN 55442, Catalog Number: 90-1431-002.
ev3 IntraStent LD DoubleStrut La Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent LD DoubleStrut
Large Diameter Biliary Stent, Model Number: S15-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-1431-000.
ev3 IntraStent LD DoubleStrut
Large Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-36,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-002.
ev3 IntraStent DoubleStrut Peripheral Stent, Model Num Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-001. Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent DoubleStrut Biliary Stent, Model Number: S11-16,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0952-000. Terminated |
FGE | K980290 |
| May 6, 2008 | Ev3, Inc ev3 IntraStent Biliary Stent, Model Number: S10-26,
ev3, 4600 Nathan Lane North, Plymouth, MN 55442, Catalog Number: 90-0648-001. Terminated |
FGE | K980290 |
| Nov 28, 2007 | Edwards Lifesciences, Llc Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614 Terminated |
FGE | K053404 |
| Apr 11, 2007 | Conmed Endoscopic Technologies, Inc. Flexxus Endoscopic Biliary Stent, 7.5 Fr
10 mm diameter x 60 mm length
Item Number: LXB10060 Terminated |
FGE | K031186 |
| Apr 11, 2007 | Conmed Endoscopic Technologies, Inc. Flexxus Endoscopic Biliary Stent, 7.5 Fr
10mm diameter x 40 mm length
Item Number: LXB10040 Terminated |
FGE | K031186 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600 Terminated |
FGE | K964119 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500 Terminated |
FGE | K964119 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400 Terminated |
FGE | K964119 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300 Terminated |
FGE | K964119 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200 Terminated |
FGE | K964119 |
| Mar 13, 2007 | Boston Scientific Corporation Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 Terminated |
FGE | K964119 |
| Feb 1, 2007 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System. SERB65-09-60-120. Terminated |
FGE | K033314 |
| Oct 28, 2006 | Cook, Inc. Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wi Terminated |
FGE | K051124 |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568. Terminated |
FGE | K033393 |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567. Terminated |
FGE | K033393 |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566. Terminated |
FGE | K033393 |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565. Terminated |
FGE | K033393 |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564. Terminated |
FGE | None listed |
| Jun 7, 2006 | Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563 Terminated |
FGE | K033393 |
| 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 | K043243 |
| May 3, 2006 | Ev3, Inc IntraStent DoubleStrut LD - Balloon Expandable Biliary Stent, Sterilized EO, ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The IntraStent DoubleStrut LD Biliary Stent is a balloon expanda Terminated |
FGE | K993904 |
| Mar 18, 2006 | Ev3, Inc ev3 Protege GPS Self-Expanding Nitinol Stent Biliary System--- Sterilization with Ethylene Oxide Gas. ev3, 4600 Nathan Lane North, Plymouth, MN 55442-2920 USA. The self-expanding stent is made of Terminated |
FGE | K011806 |
| Mar 9, 2006 | Cook, Inc. Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wi Terminated |
FGE | K051124 |
| 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 | K043243 |
| Jan 25, 2006 | Boston Scientific Scimed Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Terminated |
FGE | K032025 |
| Jan 13, 2006 | Cook, Inc. Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 6.0 mm, stent length 60 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommen Terminated |
FGE | K051124 |
| Jan 13, 2006 | Cook, Inc. Cook brand Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 7.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommen Terminated |
FGE | K051124 |
| Sep 24, 2005 | Guidant Endovascular Solutions, Inc. Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems Terminated |
FGE | K011039 K011506 +2 |
| Sep 24, 2005 | Bard Peripheral Vascular Inc Bard Luminexx 3 Biliary Stent and Delivery System Terminated |
FGE | K033497 |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x100 mm
Catalog Number: LXB10100 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 80 mm
Catalog Number: LXB10080 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 60 mm
Catalog Number: LXB10060 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 10 mm x 40 mm
Catalog Number: LXB10040 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 100 mm
Catalog Number: LXB080100 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 80 mm
Catalog Number: LXB08080 Terminated |
FGE | None listed |
| Sep 24, 2005 | Angiomed Gmbh Bard Luminexx Endoscopic Biliary Stent and Delivery System, 7.5 FR , 8 mm x 60 mm
Catalog Number: LXB08060 Terminated |
FGE | K031186 |
| Jun 28, 2005 | Wilson-Cook Medical Inc CLBS-7-12 * Cotton-Leung Biliary Stent Set * Stent Diameter: 7 Fr. * Length (Between Flaps): 12 CM. * Standard Wire Guide: .035''/480 CM. * Pushing Catheter: 7 FR. * Disposable Single Use Only- Rx On Terminated |
FGE | K851962 |
| 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 | K033314 |
| 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 | K033314 |
| 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 | K033314 |
| Oct 5, 2004 | Ev3 Biliary Stent System (6Fr 9mm x 30mm). Terminated |
FGE | K033314 |
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