Duns Number:128112195
Device Description: The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins wi The VASCADE MVP Venous Vascular Closure System (VVCS) is intended to seal femoral veins with single or multiple access sites in one or both limbs at the completion of catheterization procedures. The system is designed to deliver a resorbable Collagen Patch, extra-vascularly, at vessel puncture sites to achieve hemostasis. For use with 6Fr to 12Fr (15F maximum outer diameter) introducer sheaths; overall length of the sheath (including the hub) needs to be less than 15cm.
Catalog Number
-
Brand Name
Cardiva VASCADE MVP VVCS 6-12F
Version/Model Number
800-612C
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,P120016
Product Code
MGB
Product Code Name
Device, Hemostasis, Vascular
Public Device Record Key
96eabb31-a160-483e-87d4-4657e4757361
Public Version Date
July 12, 2021
Public Version Number
5
DI Record Publish Date
November 28, 2018
Package DI Number
M729800612C2
Quantity per Package
10
Contains DI Package
M729800612C0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |