510(k) Report

Devices descending from K031339

12 later devices reach Optibolus through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042744Optiv Antage DH Power Injection SystemMallinckrodt Inc., Liebel-Flarsheim Business2004111
+2K072886Medrad Stellant CT Injector System with P3TMedrad, Inc.20077—
+2K063503Optivantage DH Injector System with Enhanced CommunicationMallinckrodt Inc., Liebel-Flarsheim Business200721
+3K152361OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling…Liebel-Flarsheim Company, LLC20160—
+3K133600Coeur, Inc. Frontload for Optivantage Power InjectorCoeur, Inc.20140—
+3K082905Medrad Stellant CT Injector System with P3T CardiacMedrad, Inc.200952
+3K082458P3T AbdomenMedrad, Inc.20080—
+4K173773MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201841
+5K182273MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX…Bayer Medical Care, Inc.201831
+6K210541ulrichINJECT CT motionUlrich GmbH & Co. KG20211—
+6K192370MEDRAD Stellant FLEX CT Injection System with Certegra WorkstationBayer Medical Care, Inc.201901
+7K251295ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG20250—