Boston Scientific Corporation · Class II · Cleared Aug 18, 2023
| K-number | DEN230019 |
| Device name | AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mm x 10mm Stent) |
| Applicant | Boston Scientific Corporation |
| Product code | QXH |
| Device class | Class II |
| Decision date | Aug 18, 2023 |
| Decision | Not Substantially Equivalent |
| Regulation | 876.5016 |
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