510(k) K945070

VERSASAE PLASTIC CANNULA- 11 GAUGE by Imed Corp. — Product Code FPA

K945070 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "VERSASAE PLASTIC CANNULA- 11 GAUGE". The FDA issued a decision of Substantially Equivalent on January 13, 1995. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Imed Corp. has at least 10 other 510(k) clearances on record.