510(k) K203670

Extra Large Check-Flo Introducer by Cook Incorporated — Product Code DYB

K203670 is an FDA 510(k) premarket notification submitted by Cook Incorporated for the device "Extra Large Check-Flo Introducer". The FDA issued a decision of Substantially Equivalent on February 16, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Cook Incorporated has at least 10 other 510(k) clearances on record.