Duns Number:080251450
Device Description: VasCure for Vascular Repair is intended for use as a patch material for repair and reconst VasCure for Vascular Repair is intended for use as a patch material for repair and reconstruction of peripheral vasculature including the carotid, renal, iliac, femoral, and tibial blood vessels. VasCure for Vascular Repair may be used for patch closure of vessels, as a pledget, or for suture line buttressing when repairing peripheral vessels.
Catalog Number
-
Brand Name
VasCure for Vascular Repair
Version/Model Number
CMCV-013-609
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
K140789,K140789
Product Code
DXZ
Product Code Name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Public Device Record Key
7b6327b0-c122-4b1a-b8f6-4f81c55c9cdc
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
July 01, 2015
Package DI Number
10859389005147
Quantity per Package
5
Contains DI Package
00859389005140
Package Discontinue Date
-
Package Status
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 |