510(k) K943191

MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR by Boston Scientific Corp — Product Code LQC

K943191 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR". The FDA issued a decision of Substantially Equivalent on August 29, 1994. The device falls under product code LQC (Lithotriptor, Biliary Mechanical), a Class II device regulated under 21 CFR 876.4500. Boston Scientific Corp has at least 10 other 510(k) clearances on record.