510(k) K071846

MODIFICATION TO EZ HUBER SAFETY INFUSION SET by Pfm Medical, Inc. — Product Code FPA

K071846 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "MODIFICATION TO EZ HUBER SAFETY INFUSION SET". The FDA issued a decision of Substantially Equivalent on August 30, 2007. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Pfm Medical, Inc. has at least 10 other 510(k) clearances on record.