FDA Product Code DXT: Injector And Syringe, Angiographic
Leading manufacturers include Shandong Int Medical Instruments Co., Ltd., Precision Medical Plastics , Ltd. and Shenzhen Boon Medical Supply Co., Ltd..
FDA 510(k) Cleared Injector And Syringe, Angiographic Devices (Product Code DXT)
About Product Code DXT - Regulatory Context
510(k) Submission Activity
207 total 510(k) submissions under product code DXT since 1978, with 207 receiving FDA clearance (average review time: 145 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DXT have taken an average of 206 days to reach a decision - up from 142 days historically. Manufacturers should account for longer review timelines in current project planning.
DXT devices are reviewed by the General Hospital panel. Browse all General Hospital devices →