Duns Number:080251450
Device Description: VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstru VasCure for Carotid Repair is indicated for use as a patch material for vascular reconstruction and repair of the carotid artery, including patch closure following carotid endarterectomy and suture-line buttressing.
Catalog Number
-
Brand Name
VasCure for Carotid Repair
Version/Model Number
CMCV-072-606
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K111187,K111187
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
71f82373-9d7c-45f5-a965-601d1fe61680
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
July 01, 2015
Package DI Number
10859389005086
Quantity per Package
5
Contains DI Package
00859389005089
Package Discontinue Date
December 31, 2018
Package Status
Not in Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |