Duns Number:076836823
Device Description: Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungs Vi-Radius Neuro Guidewire is a stainless steel wire core with a radiopaque platinum/ tungsten coil on the distal tip. The distal portion of the wire has a hydrophilic coating.
Catalog Number
-
Brand Name
Vi-Radius
Version/Model Number
VR014205G
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 08, 2019
Issuing Agency
In HIBCC
MRI safety Status
MR Unsafe
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
K151825
Product Code
DQX
Product Code Name
Wire, Guide, Catheter
Public Device Record Key
4cbf4a96-900a-4740-8196-99a11e5726ba
Public Version Date
February 11, 2019
Public Version Number
4
DI Record Publish Date
September 28, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |