The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Sentinel Cerebral Protection System.
| Device ID | K192460 |
| 510k Number | K192460 |
| Device Name: | Sentinel Cerebral Protection System |
| Classification | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Eric Elliott |
| Correspondent | Eric Elliott Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | PUM |
| CFR Regulation Number | 870.1251 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2020-02-19 |