510(k) Report

Devices descending from K063503

2 later devices reach Optivantage DH Injector System with Enhanced Communication through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling…Liebel-Flarsheim Company, LLC20160—
+1K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.20140—