510(k) K170997

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath by Biosense Webster, Inc. — Product Code DYB

K170997 is an FDA 510(k) premarket notification submitted by Biosense Webster, Inc. for the device "CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath". The FDA issued a decision of Substantially Equivalent on Jul 25, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Biosense Webster, Inc. has 75 other 510(k) clearances on record.