510(k) K802230

BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP by Cardio Med Supplies, Inc. — Product Code FIF

K802230 is an FDA 510(k) premarket notification submitted by Cardio Med Supplies, Inc. for the device "BELLCO SINGLE NEEDLE DOUBLE HEAD PUMP". The FDA issued a decision of Substantially Equivalent on December 22, 1980. The device falls under product code FIF (Set, Dialysis, Single Needle With Uni-Directional Pump), a Class II device regulated under 21 CFR 876.5820. Cardio Med Supplies, Inc. has at least 4 other 510(k) clearances on record.