K051984 is an FDA 510(k) clearance for the FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300. This device is classified as a Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection (Class II - Special Controls, product code NFA).
Submitted by Boston Scientific Corp (Mountain View, US). The FDA issued a Cleared decision on April 10, 2006, 262 days after receiving the submission on July 22, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K051984 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 22, 2005 |
| Decision Date | April 10, 2006 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NFA — Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |