510(k) K170815

PSA Cable by Boston Scientific Corporation — Product Code DTC

K170815 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "PSA Cable". The FDA issued a decision of Substantially Equivalent on July 6, 2017. The device falls under product code DTC (Analyzer, Pacemaker Generator Function), a Class II device regulated under 21 CFR 870.3630. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.