510(k) K062909

REPEATER PUMP II TUBE SETS by Baxa Corp. — Product Code FPA

K062909 is an FDA 510(k) premarket notification submitted by Baxa Corp. for the device "REPEATER PUMP II TUBE SETS". The FDA issued a decision of Substantially Equivalent on March 9, 2007. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxa Corp. has at least 7 other 510(k) clearances on record.