510(k) K212228

WATCHMAN FXD Curve Access System by Boston Scientific Corporation — Product Code DQY

K212228 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WATCHMAN FXD Curve Access System". The FDA issued a decision of Substantially Equivalent on Aug 13, 2021. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has 238 other 510(k) clearances on record.