The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Spyglass Discover Balloon Dilation Catheter.
| Device ID | K212582 |
| 510k Number | K212582 |
| Device Name: | SpyGlass Discover Balloon Dilation Catheter |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Contact | Laura Kuroski |
| Correspondent | Laura (kuroski) Meehan Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-16 |
| Decision Date | 2022-05-06 |