510(k) Report

Devices descending from K852640

20 later devices reach Monoject Sterile 35CC Syringes through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973334OZ Power SyringeCardiovascular Innovations1998192
+2K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518—
+3K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240—
+3K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+3K140469MR Syringe Dual PackCoeur, Inc.20140—
+3K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815—
+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—
+4K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd.20092—
+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—
+6K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+6K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+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—