510(k) K895942

GESCO DUAL LUMEN PER-Q-CATH-DL by Gesco Intl., Inc. — Product Code FOZ

K895942 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO DUAL LUMEN PER-Q-CATH-DL". The FDA issued a decision of Substantially Equivalent on July 2, 1990. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.