VSI Torque Device
The VSI Torque Device gives the operator a grip for manipulating a guidewire within the vasculature. It attaches to the wire outside the patient and adds control over guidewire movement. It…
The VSI Torque Device gives the operator a grip for manipulating a guidewire within the vasculature. It attaches to the wire outside the patient and adds control over guidewire movement. It is compatible with guidewires from 0.014 to 0.038 inches in diameter.
Two oblong plastic halves snap together around the guidewire. Rotating one half locks the device onto the wire through a pin-vise clamp mechanism, so hand movement can be transferred to the secured guidewire.
Listed Item
The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Material and Sterility
The device is made from medical-grade Celanex 2401 MT plastic and is sterilized using ethylene oxide. It is a prescription accessory and has no direct or indirect patient contact.
Who Else Makes It
Concentrated in Beijing (4), Jiangsu (3), Guangdong (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Beijing Bywave Sensing Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Shanghai Achieva Medical Suzhou Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Deepintec Scientific Co., Ltd. | Beijing | Beijing | Manufacturer | 2 |
Record
| Listed by | Vascular Solutions LLC, United States |
|---|---|
| FDA product code | DQX |
| Device type | Wire, Guide, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1330 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K100093 |
| Record published | 2016-09-06 |
| Record revised | 2023-06-09 (version 6) |
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 | Box of 10 |
| Distribution end date | 2021-11-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8181 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 625 |
| Cook | Cook Incorporated | 410 |
| Guidewire | Argon Medical Devices, Inc. | 173 |
| Medline Industries, Inc. | Medline Industries, Inc. | 151 |
| Guidewire | Galt Medical Corp. | 144 |
| Amplatz | Cook Incorporated | 128 |
| InQwire® | Merit Medical Systems, Inc. | 120 |
| Angiographic Guide Wire | Medtronic, Inc. | 94 |
| Glidewire | Terumo Corp. | 83 |
| Starter™ Guidewire | Lake Region Medical Limited | 82 |
| INT,Falcon Guide Wire | Shanghai Kindly Medical Instruments Co., Ltd. | 72 |
| GuideRight™ | St. Jude Medical | 69 |
Showing 12 of 525. All products under Wire, Guide, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230637 | 2023-05-05 |
| K212167 | 2022-02-09 |
| K192454 | 2020-01-15 |
| K181647 | 2018-07-20 |
| K180128 | 2018-02-16 |
| K173532 | 2017-12-15 |
| K163444 | 2017-01-06 |
| K161702 | 2016-12-06 |
| K151234 | 2015-11-18 |
| K112631 | 2011-10-27 |
| K100093 | 2010-04-30 |
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.