FDA 510(k) Applications Submitted by Caleb Lau

FDA 510(k) Number	Submission Date	Device Name	Applicant
K231207	04/27/2023	CARTOÖ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U)	Biosense Webster, Inc.
K231312	05/05/2023	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	Biosense Webster Inc.
K231412	05/16/2023	CARTO VIZIGO« 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)	Biosense Webster, Inc.