510(k) Report

Devices descending from K192657

4 later devices reach Sterile High-pressure Angiographic Syringes for Single-use through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes…Fortis Biosolutions Company Limited20260—
+1K211564Sterile High-pressure Angiographic Syringes for Single-useShenzhen Boon Medical Supply Co., Ltd.20212—
+2K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.20260—
+2K241109Single-use Sterile High-pressure Angiographic Syringes and AccessoriesShenzhen Boon Medical Supply Co., Ltd.20240—