510(k) Report

Devices descending from K120868

1 later device reach Mega (TM) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega (TM)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K122628Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDatascope Corp., Cardiac Assist Division201203