510(k) K183036

Dilator Sets by Cook Incorporated — Product Code DRE

K183036 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Dilator Sets". The FDA issued a decision of Substantially Equivalent on December 20, 2018. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Cook Incorporated has at least 10 other 510(k) clearances on record.