510(k) K954422

PER-Q-CATH MID-LINE by Gesco Intl., Inc. — Product Code LJS

K954422 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "PER-Q-CATH MID-LINE". The FDA issued a decision of Substantially Equivalent on December 15, 1995. 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.