510(k) K233432

10F Sheath and Dilator Set by Argon Medical Devices, Inc. — Product Code DYB

K233432 is an FDA 510(k) premarket notification submitted by Argon Medical Devices, Inc. for the device "10F Sheath and Dilator Set". The FDA issued a decision of Substantially Equivalent on December 8, 2023. 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.