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) |
|---|---|---|---|
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100203CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX100201CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090803CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090801CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090603CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090601CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090403CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090401CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090303CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090301CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090203CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX090201CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080803CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080801CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080603CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080601CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080403CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080401CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080303CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080301CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080203CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX080201CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070803CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070801CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070603CD Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070601CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070403CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070401CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070303CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070203CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX070201CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060803CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060801CD. The LifeStent FlexStar self-expanding biliary stent system is Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060603CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060601CD Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060403CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060401CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060303CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060301CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060203CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Oct 10, 2008 | Bard Peripheral Vascular Inc Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifesciences LLC Irvine, CA 92614, Model EX060201CD. The LifeStent FlexStar self-expanding biliary stent system i Terminated |
FGE | K053404 |
| Sep 26, 2008 | Ev3, Inc ev3" sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.
Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080, PXB35-08-17-080 , PXB35-08-27-135 , PXB35-08-37-1 Terminated |
FGE | K061566 |
| Sep 26, 2008 | Ev3, Inc ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System.
Model Numbers: PXB35-05-12-080, PXB35-06-17-135, PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35 Terminated |
FGE | K061566 |
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in length, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105.
Used Terminated |
FGE | K851962 |
| Sep 23, 2008 | Cook Endoscopy Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC Terminated |
FGE | K851962 |
| Sep 11, 2008 | Boston Scientific Corp Boston Scientific Flexima Biliary Stent System, 200 cm long, .035" (0.89 mm), sterile, Boston Scientific, Spencer, IN; REF 3921, UPN M00539210.
System is used for delivery of the stent to the biliary Terminated |
FGE | K965147 |
| 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 | K043243 |
| Aug 26, 2008 | Ev3, Inc Ev3 Protege GPS Biliary Stent Systems
6 mm, 60 mm, 120cm, .35, 6Fr, OTW
Ev3 4600 Nathan Lane North, Plymouth, MN 55442-2920
REF SERB65-06-60-120
Lot 2675311
Use before 2009-01-01
Sterile EO
Intended Terminated |
FGE | K032580 |
| Jul 2, 2008 | Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080603CD; Edwards Lifesciences LLC, Irvine, CA 92614. Terminated |
FGE | K053404 |
| Jul 2, 2008 | Edwards Lifesciences, Llc Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD; Edwards Lifesciences LLC, Irvine, CA 92614. Terminated |
FGE | K053404 |
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