510(k) K240018

WATCHMAN TruSteer Access System (M635TU90050) by Boston Scientific Corporation — Product Code DQY

K240018 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "WATCHMAN TruSteer Access System (M635TU90050)". The FDA issued a decision of Substantially Equivalent on February 1, 2024. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.