Panels › Cardiovascular › Product code LOX · Class 2
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation 870.5100
6510(k)s in 12 months (88 all time)
0recalls in 12 months (121 all time)
29recalls that name a 510(k)
Top companies in LOX
| Company | 510(k)s | Recalls |
|---|---|---|
| Cordis Corporation | 0 | 83 |
| Abbott Vascular | 6 | 20 |
| Boston Scientific | 10 | 6 |
| Brosmed Medical | 5 | 0 |
| Ostial Corporation | 5 | 0 |
| Trireme Medical, Inc. | 5 | 0 |
| Medtronic, Inc. | 2 | 2 |
| Medtronic Ireland | 4 | 0 |
| Medtronic Vascular Galway DBA Medtronic Ireland | 0 | 4 |
| Orbusneich Medical, Inc. | 4 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.25 x 20 Dilatation Catheter, Catalog # 80120225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012020S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 . Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 20, Dual Marker Band, Dilatation Catheter, Catalog # 8012020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 20, Single Marker Band, Dilatation Catheter, Catalog # 8012015S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 20, Dual Marker Band , Dilatation Catheter, Catalog # 8012015D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.50 x 15 Dilatation Catheter, Catalog # 80115350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 . Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.25 x 15 Dilatation Catheter, Catalog # 80115325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.00 x 15 Dilatation Catheter, Catalog # 80115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.75 x 15 Dilatation Catheter, Catalog # 80115275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.50 x 15 Dilatation Catheter, Catalog # 80115250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.25 x 15 Dilatation Catheter, Catalog # 80115225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 . Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011520S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011520D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 15, Single Marker Band, Dilatation Catheter, Catalog # 8011515S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 15, Dual Marker Band, Dilatation Catheter, Catalog # 8011515D,Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.50 x 10 Dilatation Catheter, Catalog # 80110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.25 x 10 Dilatation Catheter, Catalog # 80110325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 3.00 x 10 Dilatation Catheter, Catalog # 80110300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.75 x 10 Dilatation Catheter, Catalog # 80110275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 . Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.50 x 10 Dilatation Catheter, Catalog # 80110250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.25 x 10 Dilatation Catheter, Catalog # 80110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011020S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 2.00 x 10, Dual Marker Band, Dilatation Catheter, Catalog # 8011020D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 10, Single Marker Band, Dilatation Catheter, Catalog # 8011015S, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Fire Star" 1.50 x 10, Dual Maker Band, Dilatation Catheter, Catalog # 8011015D, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 4.00 x 30 Dilatation Catheter, Catalog # 70130400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.75 x 30 Dilatation Catheter, Catalog # 70130375, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.50 x 30 Dilatation Catheter, Catalog # 70130350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.25 x 30 Dilatation Catheter, Catalog # 70130325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.00 x 30 Dilatation Catheter, Catalog # 70130300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.75 x 30 Dilatation Catheter, Catalog # 70130275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.50 x 30 Dilatation Catheter, Catalog # 70130250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.25 x 30 Dilatation Catheter, Catalog # 70130225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 4.00 x 25 Dilatation Catheter, Catalog # 70125400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.75 x 25 Dilatation Catheter, Catalog # 70125375, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.50 x 25 Dilatation Catheter, Catalog # 70125350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.25 x 25 Dilatation Catheter, Catalog # 70125325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.00 x 25 Dilatation Catheter, Catalog # 70125300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.75 x 25 Dilatation Catheter, Catalog # 70125275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.50 x 25 Dilatation Catheter, Catalog # 70125250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.25 x 25 Dilatation Catheter, Catalog # 70125225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 4.00 x 20 Dilatation Catheter, Catalog # 70120400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.75 x 20 Dilatation Catheter, Catalog # 70120375, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.50 x 20 Dilatation Catheter, Catalog # 70120350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.25 x 20 Dilatation Catheter, Catalog # 70120325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.00 x 20 Dilatation Catheter, Catalog # 70120300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.75 x 20 Dilatation Catheter, Catalog # 70120275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.50 x 20 Dilatation Catheter, Catalog # 70120250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.25 x 20 Dilatation Catheter, Catalog # 70120225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 4.00 x 15 Dilatation Catheter, Catalog # 70115400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
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