510(k) K896041

GESCO DUAL LUMEN UMBILICATH II-DL by Gesco Intl., Inc. — Product Code FOS

K896041 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "GESCO DUAL LUMEN UMBILICATH II-DL". The FDA issued a decision of Substantially Equivalent (kit, denovo) on April 17, 1990. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.