The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Axios Stent With Electrocautery Enhanced Delivery System.
| Device ID | K150692 |
| 510k Number | K150692 |
| Device Name: | AXIOS Stent With Electrocautery Enhanced Delivery System |
| Classification | Pancreatic Stent, Covered, Metallic, Removable |
| Applicant | BOSTON SCIENTIFIC CORP. 453 Ravendale Drive, Suite H Mountain View, CA 94043 |
| Contact | Carole Sykes |
| Correspondent | Carole Sykes Boston Scientific Corp. 453 RAVENDALE DRIVE, SUITE H Mountain View, CA 94043 |
| Product Code | PCU |
| CFR Regulation Number | 876.5015 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-18 |
| Decision Date | 2015-08-05 |
| Summary: | summary |