510(k) K152177

SonoStik IV Guide Wire Introducer by Sonostik, LLC — Product Code DYB

K152177 is an FDA 510(k) premarket notification submitted by Sonostik, LLC for the device "SonoStik IV Guide Wire Introducer". The FDA issued a decision of Substantially Equivalent on October 1, 2015. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Sonostik, LLC has at least 1 other 510(k) clearance on record.