The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Axios Stent And Electrocautery Enhanced Delivery System.
| Device ID | K192043 |
| 510k Number | K192043 |
| Device Name: | AXIOS Stent And Electrocautery Enhanced Delivery System |
| Classification | Pancreatic Stent, Covered, Metallic, Removable |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Kayla Mackey |
| Correspondent | Kayla Mackey Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | PCU |
| CFR Regulation Number | 876.5015 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-31 |
| Decision Date | 2019-08-26 |