510(k) K260626

Multiflex Steerable Sheath 17.5F by Vizaramed, Inc. — Product Code DYB

K260626 is an FDA 510(k) premarket notification submitted by Vizaramed, Inc. for the device "Multiflex Steerable Sheath 17.5F". The FDA issued a decision of Substantially Equivalent on March 26, 2026. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Vizaramed, Inc. has at least 1 other 510(k) clearance on record.