The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Ez Plus Retrieval Sheath, Model 38899-150.
| Device ID | K051179 |
| 510k Number | K051179 |
| Device Name: | EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 |
| Classification | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection |
| Applicant | BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. Mountain View, CA 94043 -4655 |
| Contact | Catherine A Peters |
| Correspondent | Catherine A Peters BOSTON SCIENTIFIC CORP. 2011 STIERLIN CT. Mountain View, CA 94043 -4655 |
| Product Code | NFA |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-09 |
| Decision Date | 2005-06-08 |
| Summary: | summary |