510(k) K240589

Micropuncture Introducer Sets; Micropuncture Pedal Access Sets by Cook Medical — Product Code DYB

K240589 is an FDA 510(k) premarket notification submitted by Cook Medical for the device "Micropuncture Introducer Sets; Micropuncture Pedal Access Sets". The FDA issued a decision of Substantially Equivalent on March 25, 2024. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340.