510(k) K213264

CARTO 3 EP Navigation System Version 7.2 by Biosense Webster, Inc. — Product Code DQK

K213264 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO 3 EP Navigation System Version 7.2". The FDA issued a decision of Substantially Equivalent on October 29, 2021. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.