510(k) K893646

VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY by Baxter Healthcare Corp — Product Code FPA

K893646 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY". The FDA issued a decision of Substantially Equivalent on Dec 6, 1989. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Baxter Healthcare Corp has 507 other 510(k) clearances on record.