510(k) K213846

Q2 Blood Administration Sets by Quest Medical, Inc. — Product Code FPA

K213846 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "Q2 Blood Administration Sets". The FDA issued a decision of Substantially Equivalent on June 5, 2022. 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.