510(k) K162304

Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets by Quest Medical, Inc. — Product Code FPA

K162304 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets". The FDA issued a decision of Substantially Equivalent on December 6, 2016. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.