510(k) K201112

AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP by Arrow International, Inc. — Product Code DSP

K201112 is an FDA 510(k) premarket notification submitted by Arrow International, Inc. for the device "AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP". The FDA issued a decision of Substantially Equivalent on May 27, 2020. The device falls under product code DSP (System, Balloon, Intra-Aortic And Control), a Class II device regulated under 21 CFR 870.3535. Arrow International, Inc. has at least 10 other 510(k) clearances on record.