The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Hemashield Platinum Woven Double Velour Taaa Graft Configuration.
| Device ID | K052302 |
| 510k Number | K052302 |
| Device Name: | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION |
| Classification | Graft, Vascular, Synthetic/biologic Composite |
| Applicant | BOSTON SCIENTIFIC CORP. 2 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Contact | Jennifer Bolton |
| Correspondent | Jennifer Bolton BOSTON SCIENTIFIC CORP. 2 SCIMED PLACE Maple Grove, MN 55311 -1566 |
| Product Code | MAL |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-24 |
| Decision Date | 2005-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401514428 | K052302 | 000 |
| 00384401514404 | K052302 | 000 |
| 00384401514381 | K052302 | 000 |
| 00384401018797 | K052302 | 000 |
| 00384401018780 | K052302 | 000 |
| 00384401018773 | K052302 | 000 |
| 00384401018766 | K052302 | 000 |