FDA 510(k) Applications for Medical Device Product Code "NFA"
(Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K051179 | BOSTON SCIENTIFIC CORP. | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | 06/08/2005 |
| K051984 | BOSTON SCIENTIFIC CORP. | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | 04/10/2006 |
| K052280 | BOSTON SCIENTIFIC CORP. | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | 11/07/2005 |
| K061332 | BOSTON SCIENTIFIC CORP. | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | 08/11/2006 |
| K023691 | BOSTON SCIENTIFIC EPI | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | 06/04/2003 |
| K032884 | BOSTON SCIENTIFIC EPI | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | 08/06/2004 |
| K063785 | EV3 INC | SPIDERFX EMBOLIC PROTECTION DEVICE | 01/19/2007 |
| K062201 | EV3 INC | SPIDERX EMBOLIC PROTECTION DEVICE | 08/11/2006 |
| K053195 | EV3 INC. | SPIDERX EMBOLIC PROTECTION DEVICE | 06/23/2006 |
| K061772 | KENSEY NASH CORP. | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | 07/11/2006 |
| K062870 | KENSEY NASH CORP. | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | 10/20/2006 |
| K042040 | KENSEY NASH CORP. | TRIACTIV SYSTEM | 03/23/2005 |
| K073523 | MEDTRONIC INC. | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | 08/01/2008 |
| K014223 | MEDTRONIC PERCUSURGE, INC. | MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM | 01/25/2002 |
| K013913 | MEDTRONIC PERCUSURGE, INC. | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | 11/15/2002 |
| K023303 | MEDTRONIC VASCULAR | EXPORT ASPIRATION CATHETER | 10/29/2002 |
| K023878 | MEDTRONIC VASCULAR | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | 01/24/2003 |
| K030201 | MEDTRONIC VASCULAR | MODIFICATION TO EXPORT ASPIRATION CATHETER | 03/26/2003 |
| K003992 | PERCUSURGE, INC. | PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | 06/01/2001 |
| K073563 | ST. JUDE MEDICAL | MODIFICATION TO PROXIS SYSTEM | 01/31/2008 |
| K060651 | ST. JUDE MEDICAL | PROXIS SYSTEM, MODEL EPS101 | 09/13/2006 |
| K052523 | VELOCIMED INC. | PROXIS SYSTEM | 09/07/2006 |
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