510(k) K202141

Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set by Argon Medical Devices, Inc. — Product Code DYB

K202141 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set". The FDA issued a decision of Substantially Equivalent on January 15, 2021. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical Devices, Inc. has at least 10 other 510(k) clearances on record.