510(k) K912165

LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM by Menlo Care, Inc. — Product Code FOZ

K912165 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "LANDMARK DUAL-LUMEN MIDLINE CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent (kit, denovo) on December 11, 1991. 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. Menlo Care, Inc. has at least 10 other 510(k) clearances on record.