510(k) K213002

SCORPION Portal Vein Access Set by Argon Medical Devices — Product Code DYB

K213002 is an FDA 510(k) premarket notification submitted by Argon Medical Devices for the device "SCORPION Portal Vein Access Set". The FDA issued a decision of Substantially Equivalent on October 14, 2021. 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.