510(k) K173978

CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module by Biosense Webster, Inc. — Product Code DQK

K173978 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module". The FDA issued a decision of Substantially Equivalent on Aug 24, 2018. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Biosense Webster, Inc. has 75 other 510(k) clearances on record.