510(k) Report

Devices descending from K201112

2 later devices reach AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232343AC3™ Series IABPArrow International, LLC20231—
+2K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC20250—