510(k) Report

Devices descending from K091449

3 later devices reach Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133074Mega 8FR. 50CC and Sensation Plus 8FR. 50CC Intra-Aortic Balloon Catheters and AccessoriesDatascope Corp.201309
+1K112327Sensation (TM) Plus 8FR. 50CC Intra-Aortic Balloon Catheter and AccessoriesCardiac Assist, Maquet Cardiovascular, LLC201121
+2K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203