510(k) Report

Devices descending from K063525

8 later devices reach Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpDatascope Corp.201702
+1K112372Cardiosave Hybrid Intra-Aortic Balloon PumpCardiac Assist, Maquet Cardiovascular, LLC20113Class I
+1K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+2K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+2K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+2K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+2K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203
+3K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I