510(k) Report

Devices descending from K162820

4 later devices reach AC3 Series IABP System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex20193—
+2K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.20202Class I
+3K232343AC3™ Series IABPArrow International, LLC20231—
+4K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC20250—