510(k) Report

Devices descending from K971712

20 later devices reach Coeur 130 ML Angiographic Syringe through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142745125mL CT SyringeCoeur, Inc.20150—
+1K051799Disposable CT/MR Syringes for Nemoto InjectorsCoeur, Inc.200518—
+2K242212Disposable Syringe (Kit); Nemoto Disposable Syringe (Kit)Nemoto Kyorindo Co., Ltd.20240—
+2K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT…Coeur, Inc.20170—
+2K140469MR Syringe Dual PackCoeur, Inc.20140—
+2K072696Ant Angiographic Syringes, Model (S)…Shenzhen Ant Hi-Tech Industrial Co., Ltd.200815—
+3K172694Sterile Disposable SyringesShenyang Mastech Medical Device Co., Ltd.20180—
+3K152906Disposable High Pressure Injector SyringeWuxi Yushou Medical Appliances Co., Ltd.20160—
+3K160190Sunmed Control SyringesSunny Medical Device (Shenzhen) Co., Ltd.20160—
+3K151960Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20168—
+3K082439Disposable Angiographic Syringe, Model (S) CT-200-NE, CT-200-MA, CT-200+200-MA…Shandong Weigao Medical Polymer Co., Ltd.20092—
+4K201395Sterile High-pressure Angiographic Syringes for single-useYouwo (Guangzhou) Medical Device Co., Ltd.20200—
+4K192657Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20204—
+4K182289Sterile High-pressure Angiographic Syringes for Single-useShenzhen Baoan Medical Supplies Co., Ltd.20180—
+4K170279Disposable High Pressure SyringeUnion Medical Shenzhen Co., Ltd.20170—
+4K162088Ecomed Disposable Angiographic SyringesEcomed Solutions, LLC20170—
+5K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+5K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+6K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.20260—
+6K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.20240—