510(k) K162427

Vado Bi-Directional Steerable Sheath by Kalila Medical, Inc. — Product Code DYB

K162427 is an FDA 510(k) premarket notification submitted by Kalila Medical, Inc. for the device "Vado Bi-Directional Steerable Sheath". The FDA issued a decision of Substantially Equivalent on January 27, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Kalila Medical, Inc. has at least 2 other 510(k) clearances on record.