510(k) K231312

PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID by Biosense Webster, Inc. — Product Code MTD

K231312 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID". The FDA issued a decision of Substantially Equivalent on July 10, 2023. 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.