The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Axios Stent With Delivery System, Axios Stent With Electro-cautery Enhanced Delivery System.
| Device ID | K153088 |
| 510k Number | K153088 |
| Device Name: | AXIOS Stent With Delivery System, AXIOS Stent With Electro-cautery Enhanced Delivery System |
| Classification | Pancreatic Stent, Covered, Metallic, Removable |
| Applicant | BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Ashley Santos |
| Correspondent | Ashley Santos 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 | 2015-10-26 |
| Decision Date | 2015-12-11 |
| Summary: | summary |