| DeNovo ID | DEN160043 |
| Device Name: | Sentinel Cerebral Protection System |
| Classification | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Applicant | Claret Medical, Inc. 1745 Copperhill Parkway, Suite 1 Santa Rosa, CA 95403 |
| Contact | Zachary Woodson |
| Product Code | PUM |
| CFR Regulation Number | 870.1251 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2016-09-20 |
| Decision Date | 2017-06-01 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |