Duns Number:042075700
Device Description: The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for The RadAR Vascular Compression Device Model 4160 provides economical, safe hemostasis for your post-catheterization radial access patients. The user can quickly make compression adjustements to permit patent blood flow through the artery and gradually release pressure during hemostasis, without unfastening the device. This enables patent hemostatsis which has been shown to reduce the incidence of chronic radial artery occlusion. The Model 4160 is natural in color.
Catalog Number
140-0160-00
Brand Name
RadAR Vascular Compression Device
Version/Model Number
4160
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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"
Yes
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
K142122,K142122
Product Code
DXC
Product Code Name
Clamp, Vascular
Public Device Record Key
968b64fc-8a27-40a4-b7d8-3f1cdf1357d3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20815614020085
Quantity per Package
25
Contains DI Package
10815614020088
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 27 |
| U | Unclassified | 1 |