510(k) K021964

ALPHA INFUSION PUMP AND CATHETERS by Advanced Infusion, Inc. — Product Code MEB

K021964 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "ALPHA INFUSION PUMP AND CATHETERS". The FDA issued a decision of Substantially Equivalent on August 12, 2002. The device falls under product code MEB (Pump, Infusion, Elastomeric), a Class II device regulated under 21 CFR 880.5725. Advanced Infusion, Inc. has at least 5 other 510(k) clearances on record.