510(k) K172396

EnSite Velocity Cardiac Mapping System v5.2 by St Jude Medical — Product Code DQK

K172396 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "EnSite Velocity Cardiac Mapping System v5.2". The FDA issued a decision of Substantially Equivalent on April 23, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. St Jude Medical has at least 10 other 510(k) clearances on record.