510(k) Report

Devices descending from K970689

10 later devices reach Iab-04840-U;Iab-04250-U;Iab-04240-U;Iab-04230-U through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040801Intra-Aortic Balloon (Iab)Arrow Intl., Inc.2004913
+2K063525Datascope Fiber Optic Pressure Sensor Intra-Aortic Balloon Catheter and CS300…Datascope Corp.20078Class I
+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
+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