510(k) K071330

GALTSTICK INTRODUCER SYSTEM by Galt Medical Corp. — Product Code DRE

K071330 is an FDA 510(k) premarket notification submitted by Galt Medical Corp. for the device "GALTSTICK INTRODUCER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 31, 2007. 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.