510(k) K061356

POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 by Advanced Infusion, Inc. — Product Code MED

K061356 is an FDA 510(k) premarket notification submitted by Advanced Infusion, Inc. for the device "POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6". The FDA issued a decision of Substantially Equivalent on July 3, 2006. The device falls under product code MED (Sterilant, Medical Devices), a Class II device regulated under 21 CFR 880.6885. Advanced Infusion, Inc. has at least 5 other 510(k) clearances on record.