510(k) K040533

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

K040533 is an FDA 510(k) premarket notification submitted by Pfm Medical, Inc. for the device "EZ HUBER SAFETY INFUSION SET". The FDA issued a decision of Substantially Equivalent on September 17, 2004. 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.