The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Exxcel And Exxcel Soft Eptfe Vascular Grafts, Microvel Double Velour Knitted Vascular Grafts, Woven Double Velour Woven.
| Device ID | K052964 |
| 510k Number | K052964 |
| Device Name: | EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | BOSTON SCIENTIFIC CORP. TWO SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Katie Gerbensky |
| Correspondent | Katie Gerbensky BOSTON SCIENTIFIC CORP. TWO SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-21 |
| Decision Date | 2006-01-06 |
| Summary: | summary |