The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Agile Esophageal Stent System.
| Device ID | K180144 |
| 510k Number | K180144 |
| Device Name: | Agile Esophageal Stent System |
| Classification | Prosthesis, Esophageal |
| 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 | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-18 |
| Decision Date | 2018-09-21 |
| Summary: | summary |