Panels › Cardiovascular › Product code NFA · Class 2
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation 870.1250
0510(k)s in 12 months (22 all time)
0recalls in 12 months (4 all time)
3recalls that name a 510(k)
Top companies in NFA
| Company | 510(k)s | Recalls |
|---|---|---|
| Kensey Nash Corp. | 3 | 4 |
| Boston Scientific Corp | 4 | 0 |
| Ev3, Inc. | 3 | 0 |
| Medtronic Vascular | 3 | 0 |
| Boston Scientific Epi | 2 | 0 |
| Medtronic Percusurge, Inc. | 2 | 0 |
| St Jude Medical | 2 | 0 |
| Medtronic, Inc. | 1 | 0 |
| Percu Surge, Inc. | 1 | 0 |
| Velocimed, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2006 | Kensey Nash Corp TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach. Terminated |
NFA | None listed |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes. Terminated |
NFA | K042040 |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | K042040 |
| Jul 12, 2006 | Kensey Nash Corp TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon Terminated |
NFA | K042040 |
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