510(k) Report

Devices descending from K020106

2 later devices reach Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081838Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc.20090—
+1K040355Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingGish Biomedical, Inc.200401