Product code NFA
- Device name
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1250
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K073523 | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | Medtronic, Inc. | 2008-08-01 |
| K073563 | MODIFICATION TO PROXIS SYSTEM | St Jude Medical | 2008-01-31 |
| K063785 | SPIDERFX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2007-01-19 |
| K062870 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | Kensey Nash Corp. | 2006-10-20 |
| K060651 | PROXIS SYSTEM, MODEL EPS101 | St Jude Medical | 2006-09-13 |
| K052523 | PROXIS SYSTEM | Velocimed, Inc. | 2006-09-07 |
| K062201 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-08-11 |
| K061332 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | Boston Scientific Corp | 2006-08-11 |
| K061772 | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | Kensey Nash Corp. | 2006-07-11 |
| K053195 | SPIDERX EMBOLIC PROTECTION DEVICE | Ev3, Inc. | 2006-06-23 |
| K051984 | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 | Boston Scientific Corp | 2006-04-10 |
| K052280 | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | Boston Scientific Corp | 2005-11-07 |
| K051179 | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | Boston Scientific Corp | 2005-06-08 |
| K042040 | TRIACTIV SYSTEM | Kensey Nash Corp. | 2005-03-23 |
| K032884 | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | Boston Scientific Epi | 2004-08-06 |
| K023691 | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | Boston Scientific Epi | 2003-06-04 |
| K030201 | MODIFICATION TO EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2003-03-26 |
| K023878 | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Vascular | 2003-01-24 |
| K013913 | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | 2002-11-15 |
| K023303 | EXPORT ASPIRATION CATHETER | Medtronic Vascular | 2002-10-29 |
| K014223 | MODIFICATION TO GUARDWIRE PLUS TEMPORARY OCCLUSION & ASPIRATION SYSTEM | Medtronic Percusurge, Inc. | 2002-01-25 |
| K003992 | PERCUSURGE GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | Percu Surge, Inc. | 2001-06-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08714729470854 | FilterWire EZ™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729470861 | FilterWire EZ™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729479109 | EZ Bent Tip | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729808800 | FilterWire EZ™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729808817 | FilterWire EZ™ | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 10721902644020 | GuardWire® | MEDTRONIC, INC. | 2016-09-01 |
| 10721902644037 | GuardWire® | MEDTRONIC, INC. | 2016-05-15 |
| 10721902644174 | GuardWire® | MEDTRONIC, INC. | 2016-05-15 |
| 10721902644167 | GuardWire® | MEDTRONIC, INC. | 2016-05-15 |
| 00821684040522 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040515 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040508 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040492 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040485 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040379 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040362 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040355 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040348 | SpiderFX | Covidien LP | 2015-10-16 |
| 00821684040331 | SpiderFX | Covidien LP | 2015-10-16 |