510(k) K231412

CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) by Biosense Webster, Inc. — Product Code DYB

K231412 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S)". The FDA issued a decision of Substantially Equivalent on July 10, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Biosense Webster, Inc. has at least 10 other 510(k) clearances on record.