K061332 is an FDA 510(k) clearance for the FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM). 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 August 11, 2006, 91 days after receiving the submission on May 12, 2006.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K061332 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 12, 2006 |
| Decision Date | August 11, 2006 |
| Days to Decision | 91 days |
| Submission Type | Special |
| 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 |