NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection Class II
FDA product code NFA covers "Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NFA
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K073523 | medtronic | INTERCEPTOR PLUS CORONARY FILTER SYSTEMS | August 1, 2008 |
| K073563 | st jude medical | MODIFICATION TO PROXIS SYSTEM | January 31, 2008 |
| K063785 | ev3 | SPIDERFX EMBOLIC PROTECTION DEVICE | January 19, 2007 |
| K062870 | kensey nash | TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03 | October 20, 2006 |
| K060651 | st jude medical | PROXIS SYSTEM, MODEL EPS101 | September 13, 2006 |
| K052523 | velocimed | PROXIS SYSTEM | September 7, 2006 |
| K061332 | boston scientific | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) | August 11, 2006 |
| K062201 | ev3 | SPIDERX EMBOLIC PROTECTION DEVICE | August 11, 2006 |
| K061772 | kensey nash | TRIACTIV FX EMBOLIC PROTECTION SYSTEM | July 11, 2006 |
| K053195 | ev3 | SPIDERX EMBOLIC PROTECTION DEVICE | June 23, 2006 |
| K051984 | boston scientific | FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20 | April 10, 2006 |
| K052280 | boston scientific | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM | November 7, 2005 |
| K051179 | boston scientific | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 | June 8, 2005 |
| K042040 | kensey nash | TRIACTIV SYSTEM | March 23, 2005 |
| K032884 | boston scientific epi | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH | August 6, 2004 |
| K023691 | boston scientific epi | BOSTON SCIENTIFIC FILTERWIRE EX EMBOLIC | June 4, 2003 |
| K030201 | medtronic vascular | MODIFICATION TO EXPORT ASPIRATION CATHETER | March 26, 2003 |
| K023878 | medtronic vascular | GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | January 24, 2003 |
| K013913 | medtronic percusurge | PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM | November 15, 2002 |
| K023303 | medtronic vascular | EXPORT ASPIRATION CATHETER | October 29, 2002 |