510(k) K910622

GESCO PER-Q-CATH REPAIR KIT by Gesco Intl., Inc. — Product Code LJS

K910622 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO PER-Q-CATH REPAIR KIT". The FDA issued a decision of Substantially Equivalent (kit) on March 29, 1991. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.