510(k) K210734

Endovascular Dilator and Sets by Cook Incorporated — Product Code DRE

K210734 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Endovascular Dilator and Sets". The FDA issued a decision of Substantially Equivalent on April 6, 2021. 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.