The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Ureteral Stent Systems, Biliary Drainage Catheters.
| Device ID | K191446 |
| 510k Number | K191446 |
| Device Name: | Ureteral Stent Systems, Biliary Drainage Catheters |
| Classification | Stent, Ureteral |
| Applicant | Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Jois Zuniga Gamboa |
| Correspondent | Jois Zuniga Gamboa Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-31 |
| Decision Date | 2020-01-02 |