510(k) K842351

STERILE DESIGN-CUSTOM STERILE IV KIT by Sterile Design, Inc. — Product Code FPA

K842351 is an FDA 510(k) premarket notification submitted by Sterile Design, Inc. for the device "STERILE DESIGN-CUSTOM STERILE IV KIT". The FDA issued a decision of Substantially Equivalent on October 15, 1984. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterile Design, Inc. has at least 9 other 510(k) clearances on record.