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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2008 | K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS Medtronic, Inc. | NFA |
| Jan 31, 2008 | K073563 | MODIFICATION TO PROXIS SYSTEM St Jude Medical | NFA |
| Jan 19, 2007 | K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Oct 20, 2006 | K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 Kensey Nash Corp. | NFA |
| Sep 13, 2006 | K060651 | PROXIS SYSTEM, MODEL EPS101 St Jude Medical | NFA |
| Sep 7, 2006 | K052523 | PROXIS SYSTEM Velocimed, Inc. | NFA |
| Aug 11, 2006 | K062201 | SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Aug 11, 2006 | K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) Boston Scientific Corp | NFA |
| Jul 11, 2006 | K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM Kensey Nash Corp. | NFA |
| Jun 23, 2006 | K053195 | SPIDERX EMBOLIC PROTECTION DEVICE Ev3, Inc. | NFA |
| Apr 10, 2006 | K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 Boston Scientific Corp | NFA |
| Nov 7, 2005 | K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM Boston Scientific Corp | NFA |
| Jun 8, 2005 | K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 Boston Scientific Corp | NFA |
| Mar 23, 2005 | K042040 | TRIACTIV SYSTEM Kensey Nash Corp. | NFA |
| Aug 6, 2004 | K032884 | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH Boston Scientific Epi | NFA |
| Jun 4, 2003 | K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC Boston Scientific Epi | NFA |
| Mar 26, 2003 | K030201 | MODIFICATION TO EXPORT ASPIRATION CATHETER Medtronic Vascular | NFA |
| Jan 24, 2003 | K023878 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Medtronic Vascular | NFA |
| Nov 15, 2002 | K013913 | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Medtronic Percusurge, Inc. | NFA |
| Oct 29, 2002 | K023303 | EXPORT ASPIRATION CATHETER Medtronic Vascular | NFA |
| Jan 25, 2002 | K014223 | MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM Medtronic Percusurge, Inc. | NFA |
| Jun 1, 2001 | K003992 | PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM Percu Surge, Inc. | NFA |
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