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 7, 2003 | Medtronic Ave Inc Medtronic AVE brand BridgeAssurant Balloon Expandable Stent Delivery System
for Biliary Catheter;Model #s:
FB720VF, FB730 VF, FB740 VF, FB760 VF, FB820VF, FB830VF, FB840VF, FB860VF;
FB720VL, FB730VL, Terminated |
FGE | None listed |
| Apr 2, 2003 | Cordis Corporation The device is Labeled as SMART Control TRANSHEPATIC BILIARY STENT REF (PRODUCT NUMBER LISTED), VARIOUS LABELED SIZES . and lot numbers.
Product is packed in a Tyvek pouch and further packed into a sh Terminated |
FGE | K021898 K023217 |
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