510(k) K863814

BAG SPIKE EXTENSION SET by Med Fusion Systems, Inc. — Product Code FPA

K863814 is an FDA 510(k) premarket notification submitted by Med Fusion Systems, Inc. for the device "BAG SPIKE EXTENSION SET". The FDA issued a decision of Substantially Equivalent on October 14, 1986. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Med Fusion Systems, Inc. has at least 10 other 510(k) clearances on record.