# Shanghai INT Medical Instruments Co., Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shanghai INT Medical Instruments Co., Ltd. · 89-08 · CHINA, import alert is 89-08; 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)"; country is CHINA; 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 2026-09-16.

- **Firm:** Shanghai INT Medical Instruments Co., Ltd. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** CHINA _(verified: appears in the quote below)_
- **Address:** Jinyuan 925 , Yi Rd , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 02/17/2026 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_
- **FDA notes:** KDL Angiography Catheter | Guidewire | KDL Micro catheter | Y-Connector Kit | High Pressure Tubing | Angiography Syringe | Introducer Set | INT Introducer Set | nflation Device | INT Vacuum Locking Syringe | Medical Face Mask | INT Vacuum Locking Syringe _(verified: each item appears in the quote below)_

## What the source says

> Shanghai INT Medical Instruments Co., Ltd. Date Published : 02/17/2026 Jinyuan 925 , Yi Rd , Shanghai, Shanghai CHINA 74 D - - QO Catheter, Intravascular, Diagnostic Date Published: 02/17/2026 Desc: KDL Angiography Catheter Notes: KDL Angiography Catheter 74 D - - QX Wire, Guide, Catheter Date Published: 02/17/2026 Desc: Guidewire Notes: Guidewire 74 D - - QY Catheter, Percutaneous Date Published: 02/17/2026 Desc: KDL Micro catheter Notes: KDL Micro catheter 74 D - - TL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Date Published: 02/17/2026 Desc: Y-Connector Kit Notes: Y-Connector Kit 74 D - - XT Injector And Syringe, Angiographic Date Published: 02/17/2026 Desc: High Pressure Tubing Notes: High Pressure Tubing 74 D - - XT Injector And Syringe, Angiographic Date Published: 02/17/2026 Desc: Angiography Syringe Notes: Angiography Syringe 74 D - - YB Introducer, Catheter Date Published: 02/17/2026 Desc: Introducer Set Notes: Introducer Set 74 D - - YB Introducer, Catheter Date Published: 02/17/2026 Desc: INT Introducer Set Notes: INT Introducer Set 74 M - - AV Syringe, Balloon Inflation Date Published: 02/17/2026 Desc: Inflation Device Notes: nflation Device 80 F - - MF Syringe, Piston Date Published: 02/17/2026 Desc: INT Vacuum Locking Syringe Notes: INT Vacuum Locking Syringe 80 F - - XX Mask, Surgical Date Published: 02/17/2026 Desc: Medical Face Mask Notes: Medical Face Mask 80 P - - UR Vacuum syringe Date Published: 02/17/2026 Desc: INT Vacuum Locking Syringe Notes: INT Vacuum Locking Syringe

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).