510(k) K053501

POWERPICC by Bard Access Systems, Inc. — Product Code LJS

K053501 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "POWERPICC". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.