510(k) K021216

SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS by Sterling Medivations, Inc. — Product Code FPA

K021216 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICTY SIMPLEX P INFUSION SET FOR USE WITH THE MINIMED PARADIGM INFUSION PUMPS". The FDA issued a decision of Substantially Equivalent on May 3, 2002. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.