510(k) Report

Devices descending from K822536

44 later devices reach MARK V through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973334OZ Power SyringeCardiovascular Innovations1998192
+1K963982Acist Angiographic InjectorInvasatec199723—
+2K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518—
+2K991103Modification to Acist CL 100HAcist Medical Systems2000193
+2K984231Angiographic Contrast Management System, Model Part a and Part BInvasatec2000204
+2K984058Acist Injector System, Model CL100 HAcist Medical Systems199920—
+3K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240—
+3K171646ACISTCVi® Contrast Delivery SystemAcist Medical Systems, Inc.20184—
+3K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+3K140469MR Syringe Dual PackCoeur, Inc.20140—
+3K131478Contrast Conservation SystemOsprey Medical, Inc.201313—
+3K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815—
+3K052744C2000 Automated Manifold KitAcist Medical Systems, Inc.2005141
+4K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module…Acist Medical Systems, Inc.20260—
+4K191060ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000…Acist Medical Systems, Inc.20192—
+4K172694Sterile Disposable SyringesShenyang Mastech Medical Device Co., Ltd.20180—
+4K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd.20160—
+4K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+4K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20168—
+4K140425Contrast Modulation SystemOsprey Medical, Inc.201412—
+4K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd.20092—
+5K203004ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery SystemAcist Medical Systems, Inc.20201—
+5K201395Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd.20200—
+5K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20204—
+5K182289Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20180—
+5K170279Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd.20170—
+5K162088Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC20170—
+5K151300AVERT Contrast Modulation SystemOsprey Medical, Inc.20158—
+5K151746Dyevert Contrast Modulation SystemOsprey Medical, Inc.20158—
+5K152218AVERT Contrast Modulation System;AVERT Contrast Modulation System;AVERT Contrast…Osprey Medical20150—
+5K150485AVERT Contrast Modulation SystemOsprey Medical, Inc.201510—
+6K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+6K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use…Acist Medical Systems, Inc.20260—
+6K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+6K153141DyeVert Contrast Modulation SystemOsprey Medical, Inc.20167—
+7K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.20260—
+7K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.20240—
+7K161505DyeVert NG Contrast Modulation SystemOsprey Medical, Inc.20166—
+8K183267DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System…Osprey Medical, Inc.20180—
+8K171217DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction SystemOsprey Medical, Inc.20171—
+8K163054DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring SystemOsprey Medical, Inc.20175—
+9K190102DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™…Osprey Medical, Inc.20190—
+9K181936DyeVert PLUS EZ Contrast Reduction SystemOsprey Medical, Inc.20182—
+9K171698Smart SyringeOsprey Medical, Inc.20171—