510(k) Report

Devices descending from K981660

19 later devices reach Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+1K021462Arrow Intra-Aortic Balloon (Iab) Catheter with a Fiber Optic Sensor and a Measurement…Arrow Intl., Inc.200218Class I
+2K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.20200Class I
+2K190117Fiberoptix IABArrow International, Inc.20191—
+2K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+2K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+2K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+2K060309Autocat Intra-Aortic Balloon Pump SeriesArrow Intl., Inc.200614Class I
+2K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc.2004913
+3K201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.20202Class I
+3K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+3K162820AC3 Series IABP SystemArrow International, Inc.20174Class I
+3K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+3K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+3K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+4K232343AC3™ Series IABPArrow International, LLC20231—
+4K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, Teleflex20193—
+4K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I
+5K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLC20250—