The following data is part of a premarket notification filed by Boston Scientific Epi with the FDA for Filter Wire Ez Embolic Protection System And Ez Bent Tip Retrieval Sheath.
| Device ID | K032884 |
| 510k Number | K032884 |
| Device Name: | FILTER WIRE EZ EMBOLIC PROTECTION SYSTEM AND EZ BENT TIP RETRIEVAL SHEATH |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | BOSTON SCIENTIFIC EPI 2525 WALSH AVE. Santa Clara, CA 95051 -1316 |
| Contact | Debbie Mcintire |
| Correspondent | Debbie Mcintire BOSTON SCIENTIFIC EPI 2525 WALSH AVE. Santa Clara, CA 95051 -1316 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-16 |
| Decision Date | 2004-08-06 |
| Summary: | summary |