510(k) K212262

PCA Syringe Sets by Baxter Healthcare Corporation — Product Code FPA

K212262 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corporation for the device "PCA Syringe Sets". The FDA issued a decision of Substantially Equivalent on October 3, 2022. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corporation has at least 10 other 510(k) clearances on record.