510(k) Report

Devices descending from K965209

18 later devices reach Acat 1 (Arrow Cardiac Assist Technology 1) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc.200614Class I
+1K002256Arrow Acat 2 Intra-Aortic Balloon PumpArrow Intl., Inc.200117—
+2K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.20202Class I
+2K162820AC3 Series IABP SystemArrow International, Inc.20174Class I
+2K070225Supracor Intr-Aortic Balloon Pump ConsoleAbiomed, Inc.20070—
+2K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+2K020257Datascope's 8FR. Alt B Iab; Datascope's Profile 8FR. Alt B Iab; Datascope's True…Datascope Corp.20020—
+3K232343AC3™ Series IABPArrow International, LLC20231—
+3K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex20193—
+3K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+3K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+3K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+4K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC20250—
+4K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+4K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+4K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+4K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+5K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I