Shanghai INT Medical Instruments Co., Ltd. · 89-08 · CHINA

For Shanghai INT Medical Instruments Co., Ltd., import alert is 89-08; country is CHINA; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; product is KDL Angiography Catheter | Guidewire | KDL Micro catheter | Y-Connector Kit | High Pressure Tubing | Angiography Syringe | Introducer Set | INT Introducer Set | Inflation Device | INT Vacuum Locking Syringe | Medical Face Mask | INT Vacuum Locking Syringe; product code is 74 D - - QO Catheter, Intravascular, Diagnostic | 74 D - - QX Wire, Guide, Catheter | 74 D - - QY Catheter, Percutaneous | 74 D - - TL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 74 D - - XT Injector And Syringe, Angiographic | 74 D - - XT Injector And Syringe, Angiographic | 74 D - - YB Introducer, Catheter | 74 D - - YB Introducer, Catheter | 74 M - - AV Syringe, Balloon Inflation | 80 F - - MF Syringe, Piston | 80 F - - XX Mask, Surgical | 80 P - - UR Vacuum syringe; date published is 02/17/2026; address is Jinyuan 925 , Yi Rd , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.

What the source says

Shanghai INT Medical Instruments Co., Ltd. Date Published : 02/17/2026 Jinyuan 925 , Yi Rd , Shanghai, Shanghai CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

— all from accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-30. Due for re-check by 2026-11-29. This page as Markdown · OKF bundle · full dataset as JSON.