Duns Number:128112195
Device Description: The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of cat The VASCADE VCS is intended to seal femoral vessel puncture sites at the completion of catheter-based procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at the vessel puncture site to achieve hemostasis. For use in 5F introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
Catalog Number
-
Brand Name
Cardiva VASCADE 5F VCS
Version/Model Number
700-500DX
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Safe
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
P120016,P120016,P120016
Product Code
MGB
Product Code Name
Device, Hemostasis, Vascular
Public Device Record Key
1a7a7400-f3e3-43b2-b217-ad7187ba4e33
Public Version Date
July 09, 2021
Public Version Number
8
DI Record Publish Date
December 29, 2015
Package DI Number
M729700500DX1
Quantity per Package
5
Contains DI Package
M729700500DX0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
5-pk carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |