510(k) K192195

Sterile Dilator by Galt Medical Corp. — Product Code DRE

K192195 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "Sterile Dilator". The FDA issued a decision of Substantially Equivalent on September 26, 2019. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Galt Medical Corp. has at least 10 other 510(k) clearances on record.