Duns Number:008999906
Device Description: The VSI Torque Device is intended for use in manipulating a guidewire that is in the vascu The VSI Torque Device is intended for use in manipulating a guidewire that is in the vasculature.
Catalog Number
-
Brand Name
VSI Torque Device
Version/Model Number
8181
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K100093,K100093
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
f89b49b2-33ee-4604-bbcf-0f5245354282
Public Version Date
June 15, 2020
Public Version Number
5
DI Record Publish Date
September 06, 2016
Package DI Number
M20681811
Quantity per Package
10
Contains DI Package
M20681810
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 238 |
| U | Unclassified | 12 |