The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Exxcel Soft Eptee Vascular Graft-standard Wall,thin Wall.
| Device ID | K113101 |
| 510k Number | K113101 |
| Device Name: | EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | Boston Scientific Corporation 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Susan Eichler-huston |
| Correspondent | Susan Eichler-huston Boston Scientific Corporation 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-19 |
| Decision Date | 2012-01-17 |
| Summary: | summary |