510(k) K201750

Pentaray Nav eco High-Density Mapping Catheter by Biosense Webster, Inc. — Product Code MTD

K201750 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "Pentaray Nav eco High-Density Mapping Catheter". The FDA issued a decision of Substantially Equivalent on August 6, 2020. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.