VSI Tru-Torque™ Guidewire
The VSI Tru-Torque Steerable Guidewire facilitates placement of a catheter during diagnostic angiography and interventional procedures. The VSI Tru-Torque can be accurately controlled ot…
The VSI Tru-Torque Steerable Guidewire facilitates placement of a catheter during diagnostic angiography and interventional procedures. The VSI Tru-Torque can be accurately controlled ot facilitate navigation through tortuous vessels and/or adjoining side branches.
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 |
| Record published | 2016-09-05 |
| Record revised | 2024-05-28 (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 |
| Packaging | Box of 5 |
| Sizes | Length 150 to 300 cm; outer diameter 0.035 in |
| Distribution end date | 2024-09-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7474 | Outer Diameter 0.035 in | Withdrawn |
| 7470 | Length 150 cm | Withdrawn |
| 7472 | Outer Diameter 0.035 in | Withdrawn |
| 7476 | Outer Diameter 0.035 in | Withdrawn |
| 7473 | Outer Diameter 0.035 in | Withdrawn |
| 7477 | Outer Diameter 0.035 in | Withdrawn |
| 7471 | Outer Diameter 0.035 in | Withdrawn |
| 7478 | Outer Diameter 0.035 in | Withdrawn |
| 7475 | Outer Diameter 0.035 in | 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.