510(k) K213638

Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) by Argon Medical Devices — Product Code DYB

K213638 is an FDA 510(k) premarket notification submitted by Argon Medical Devices for the device "Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)". The FDA issued a decision of Substantially Equivalent on December 10, 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.