510(k) K891022

INTRODUCER FOR PTCA GUIDING CATHETERS by Argon Medical Corp. — Product Code DYB

K891022 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "INTRODUCER FOR PTCA GUIDING CATHETERS". The FDA issued a decision of Substantially Equivalent on May 19, 1989. 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.