510(k) K162804

Q2 Low Pressure Power Injection Extension Set by Quest Medical, Inc. — Product Code FPA

K162804 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "Q2 Low Pressure Power Injection Extension Set". The FDA issued a decision of Substantially Equivalent on March 8, 2017. 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.