510(k) K912358

LANDMARK ADD-A-LUMEN CATHETER KIT by Menlo Care, Inc. — Product Code FOZ

K912358 is an FDA 510(k) premarket notification submitted by Menlo Care, Inc. for the device "LANDMARK ADD-A-LUMEN CATHETER KIT". The FDA issued a decision of Substantially Equivalent (kit, denovo) on January 2, 1992. 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.