510(k) K953791

VLV SA EF INFUSION PORT by Vlv Associates, Inc. — Product Code FPA

K953791 is an FDA 510(k) premarket notification submitted by Vlv Associates, Inc. for the device "VLV SA EF INFUSION PORT". The FDA issued a decision of Substantially Equivalent on October 30, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Vlv Associates, Inc. has at least 10 other 510(k) clearances on record.