Boston Scientific Corporation · Class II · Cleared Sep 5, 2008
| K-number | K080332 |
| Device name | POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 |
| Applicant | Boston Scientific Corporation |
| Product code | ESW |
| Device class | Class II |
| Decision date | Sep 5, 2008 |
| Decision | Substantially Equivalent |
| Regulation | 878.3610 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov