K032884 is an FDA 510(k) clearance for the FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH. 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 Epi (Santa Clara, US). The FDA issued a Cleared decision on August 6, 2004, 325 days after receiving the submission on September 16, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K032884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 16, 2003 |
| Decision Date | August 06, 2004 |
| Days to Decision | 325 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 |