510(k) K894842

IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM by Imed Corp. — Product Code FPA

K894842 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "IMED GEMINI 12 NONVENTED Y-TYPE BLOOD/SOLUTION ADM". The FDA issued a decision of Substantially Equivalent on September 12, 1989. 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.