510(k) K882221

OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE by Argon Medical Corp. — Product Code DYB

K882221 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE". The FDA issued a decision of Substantially Equivalent on August 12, 1988. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Argon Medical Corp. has at least 10 other 510(k) clearances on record.