510(k) Report

Devices descending from K112372

3 later devices reach Cardiosave Hybrid Intra-Aortic Balloon Pump through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181122CARDIOSAVE Intra-Aortic Balloon PumpDatascope Corp.20180Class I
+1K151254CARDIOSAVE Hybrid Intra-Aortic Balloon PumpDatascope Corp.20151Class I
+2K163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery…Datascope Corp.20170Class I