510(k) K950153

VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES by Imed Corp. — Product Code FPA

K950153 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "VENTED/NONVENTED GEMINI ADMINISTRATION SET WITH CHECK VALVE AND TWO SAFSITE(TM) VALVES". The FDA issued a decision of Substantially Equivalent on August 24, 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.