510(k) K915167

GESCO PER-Q-CATH CATHETER INTRODUCER by Gesco Intl., Inc. — Product Code DYB

K915167 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO PER-Q-CATH CATHETER INTRODUCER". The FDA issued a decision of Substantially Equivalent on January 27, 1992. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.