510(k) Report

Devices descending from K934763

4 later devices reach Sorin Blood Cardioplegia System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD…Sorin Group Italia S.R.L.20250—
+1K020106Vision Blood Cardioplegia System and Extracorporeal Heat ExchangerGish Biomedical, Inc.20022—
+2K081838Gish Vision Blood Cardioplegia with HA CoatingGish Biomedical, Inc.20090—
+2K040355Vision Blood Cardioplegia System and Extracorporal Heat Exchanger with GBS CoatingGish Biomedical, Inc.200401