510(k) K192460

Sentinel Cerebral Protection System by Boston Scientific Corporation — Product Code PUM

K192460 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "Sentinel Cerebral Protection System". The FDA issued a decision of Substantially Equivalent on February 19, 2020. The device falls under product code PUM (Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures), a Class II device regulated under 21 CFR 870.1251. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.