The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Filterwire Ez Embolic Protection System.
| Device ID | K052280 |
| 510k Number | K052280 |
| Device Name: | FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. Mountain View, CA 94043 -4655 |
| Contact | Debbie Mcintire |
| Correspondent | Debbie Mcintire BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. Mountain View, CA 94043 -4655 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-22 |
| Decision Date | 2005-11-07 |
| Summary: | summary |