K192460 is an FDA 510(k) clearance for the Sentinel Cerebral Protection System. This device is classified as a Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures (Class II - Special Controls, product code PUM).
Submitted by Boston Scientific Corporation (Maple Grove, US). The FDA issued a Cleared decision on February 19, 2020, 163 days after receiving the submission on September 9, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1251. Embolic Protection For Transcatheter Intracardiac Procedures.
| 510(k) Number | K192460 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 09, 2019 |
| Decision Date | February 19, 2020 |
| Days to Decision | 163 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PUM — Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1251 |
| Definition | Embolic Protection For Transcatheter Intracardiac Procedures |