Duns Number:008999906
Device Description: The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of gui The VSI Radial Introducer Sheath is intended for use to facilitate the introduction of guidewires, catheters and other accessory medical devices through the skin into a vein or artery and minimize blood loss associated with such introduction.
Catalog Number
-
Brand Name
VSI Radial™ introducer sheath
Version/Model Number
9002
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 30, 2019
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
K140768,K140768
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
a017ffd3-4ca5-461d-89fe-055d62779382
Public Version Date
July 23, 2019
Public Version Number
5
DI Record Publish Date
September 05, 2016
Package DI Number
M20690021
Quantity per Package
5
Contains DI Package
M20690020
Package Discontinue Date
June 30, 2019
Package Status
Not 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 |