510(k) K912111

MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE by Gerard Medical Enterprises, Inc. — Product Code FMF

K912111 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE". The FDA issued a decision of Substantially Equivalent on October 8, 1991. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Gerard Medical Enterprises, Inc. has at least 7 other 510(k) clearances on record.