510(k) K182914

MC3 Vascular Access Kit 21030 by Mc3 Incorporated — Product Code DRE

K182914 is an FDA 510(k) premarket notification submitted by Mc3 Incorporated for the device "MC3 Vascular Access Kit 21030". The FDA issued a decision of Substantially Equivalent on October 29, 2018. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Mc3 Incorporated has at least 3 other 510(k) clearances on record.