510(k) K230631

Kodiak™ Dual Port Coaxial Introducer Kit by Argon Medical Devices — Product Code DYB

K230631 is an FDA 510(k) premarket notification submitted by Argon Medical Devices for the device "Kodiak™ Dual Port Coaxial Introducer Kit". The FDA issued a decision of Substantially Equivalent on May 22, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical Devices has at least 10 other 510(k) clearances on record.