Vasoshield
Vasoshield Pressure Controlling Syringe
24manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation
Record
| Listed by | Maquet Cardiovascular LLC, United States |
|---|---|
| FDA product code | GBX |
| Device type | Catheter, Irrigation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2025-02-06 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | 5 pack box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VH-5001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| One-Step™ | Merit Medical Systems, Inc. | 167 |
| Cardinal Health | Cardinal Health 200, LLC | 109 |
| Cook | Cook Incorporated | 85 |
| ReSolve® | Merit Medical Systems, Inc. | 68 |
| Pleur-Evac | Teleflex Medical LLC | 66 |
| Jackson-Pratt | Cardinal Health 200, LLC | 47 |
| Total Abscession | AngioDynamics, Inc. | 36 |
| Channel Drain | C.R. Bard, Inc. | 36 |
| ReSolve Mini™ | Merit Medical Systems, Inc. | 32 |
| Silicone Tubing, Radiopaque | Bentec Medical OpCo, LLC. | 25 |
| Blake | Ethicon, Inc. | 19 |
| Silicone Tubing, Translucent | Bentec Medical OpCo, LLC. | 19 |
Showing 12 of 223. All products under Catheter, Irrigation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K082725 | 2008-12-17 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Maquet Cardiovascular LLC | UDI-DI | 2022-12-22 | Class II | Under Investigation by firm | Ink on the Vasoshield syringe Maquet logo may chip resulting in an unreasonable risk of harm to the patient. Potential harms may include foreign body reaction, coronary embolic event, and peripheral embolic event. | 530 units US, 215 units OUS |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.