VasoStat Hemostasis Device
The VasoStat Hemostasis Device applies adjustable compression over a vascular puncture site to help stop bleeding. Medical professionals use it after catheterisation or other vessel…
The VasoStat Hemostasis Device applies adjustable compression over a vascular puncture site to help stop bleeding. Medical professionals use it after catheterisation or other vessel punctures in the arm or lower leg, including arterial or venous line removal and dialysis access.
A flexible thermoplastic base adheres to the skin with adhesive pads. A plunger passes through the base and uses a ratcheting mechanism to apply targeted pressure. The operator can adjust the pressure with one hand to suit the puncture site.
Listed Item
The VasoStat Hemostasis Device is used to augment hemostasis through a ratcheting pressure mechanism.
Removal
The device is removed and discarded once haemostasis is achieved. Its indication includes patients receiving anticoagulation therapy, with compression applied locally at the vessel access site.
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Wickimed (Huizhou) Medical Equipment Manufacturing Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 3 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Terumo Medical Products (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
Record
| Listed by | Forge Medical, Inc., United States |
|---|---|
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| 510(k) | K153259 |
| Record published | 2021-05-27 |
| Record revised | 2023-06-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dark, dry, cool place. Avoid extended exposure to light. |
| Packaging | Carton of 10, shipper, shipper of 2, shipper of 3, shipper of 4 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10348-325-04 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 831 |
| Novo Surgical | Novo Surgical, Inc. | 708 |
| Ambler Surgical | Ambler Surgical, LLC | 575 |
| Pilling | Teleflex Medical LLC | 544 |
| Avalign | Avalign Technologies, Inc. | 543 |
| Boss Instruments | Boss Instruments, Ltd. | 457 |
| V. Mueller | Steris Corporation | 432 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 342 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 331 |
| Scanlan® | Scanlan International, Inc. | 294 |
| HNM Medical | HNM Stainless, LLC. | 230 |
| Aesculap | Aesculap AG | 136 |
Showing 12 of 639. All products under Clamp, Vascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K153259 | 2016-01-06 |
| K123041 | 2013-05-29 |
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.