510(k) K021080

NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS by Cardio Med Supplies, Inc. — Product Code FPA

K021080 is an FDA 510(k) premarket notification submitted by Cardio Med Supplies, Inc. for the device "NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS". The FDA issued a decision of Substantially Equivalent on August 29, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Cardio Med Supplies, Inc. has at least 4 other 510(k) clearances on record.