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 "Dura Star" 3.75 x 15 Dilatation Catheter, Catalog # 70115375, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.50 x 15 Dilatation Catheter, Catalog # 70115350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.25 x 15 Dilatation Catheter, Catalog # 70115325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.00 x 15 Dilatation Catheter, Catalog # 70115300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.75 x 15 Dilatation Catheter, Catalog # 70115275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.50 x 15 Dilatation Catheter, Catalog # 70115250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.25 x 15 Dilatation Catheter, Catalog # 70115225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 4.00 x 10 Dilatation Catheter, Catalog # 70110400, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.75 x 10 Dilatation Catheter, Catalog # 70110375, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.50 x 10 Dilatation Catheter, Catalog # 70110350, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.25 x 10 Dilatation Catheter, Catalog # 70110325, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 3.00 x 10 Dilatation Catheter, Catalog # 70110300, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.75 x 10 Dilatation Catheter, Catalog # :70110275, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.50 x 10 Dilatation Catheter, Catalog # 70110250, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Feb 6, 2008 | Cordis Corporation CORDIS "Dura Star" 2.25 x 10 Dilatation Catheter, Catalog # 70110225, Distributed by Cordis Corporation, Miami Lakes, FL 33014 Terminated |
LOX | None listed |
| Sep 23, 2006 | Boston Scientific Boston Scientific Cutting Balloon Ultra2 Monorail Device, Boston Scientific, One Boston Scientific Place, Natick, MA 01760. Terminated |
LOX | None listed |
| Jul 20, 2004 | Medtronic Vascular Percutaneous Transluminal Coronary Angioplasty system in sterile pouch. Terminated |
LOX | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151 Terminated |
LOX | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051 Terminated |
LOX | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011 Terminated |
LOX | None listed |
| Mar 6, 2003 | Medtronic, Inc. Medtronic AVE Everest PTCA Inflation Catheter 20 cc
Item #AC2200 Terminated |
LOX | K942269 |
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