510(k) K173287

Elite HV Radial by Galt Medical Corp. — Product Code DYB

K173287 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "Elite HV Radial". The FDA issued a decision of Substantially Equivalent (kit) on December 21, 2017. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Galt Medical Corp. has at least 10 other 510(k) clearances on record.