510(k) Report

Devices descending from K896807

7 later devices reach SPBC Series Single Pass Blood Cardioplegia System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020106Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc.20022—
+1K960755Cardiotherm Blood Cardioplegia SystemsMedtronic Cardiac Surgery, Medtronic, Inc.19963—
+2K081838Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc.20090—
+2K040355Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingGish Biomedical, Inc.200401
+2K991137Enguard PHX Cardioplegia Heat ExchangerMinntech Corp.20000—
+2K973237CSS-Cardioplegia Safety SystemMedtronic Bio-Medicus, Inc.19980—
+2K973475Carmeda Coated Cardiotherm Blood Cardioplegia Systems (Cbctxxx Series and Cbctxxxbr…Medtronic Vascular19970—