The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Tria Soft Ureteral Stent.
| Device ID | K191609 |
| 510k Number | K191609 |
| Device Name: | Tria Soft Ureteral Stent |
| Classification | Stent, Ureteral |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Justin Kapitan |
| Correspondent | Justin Kapitan Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-17 |
| Decision Date | 2019-08-16 |