Duns Number:320047483
Device Description: COVERA™ Vascular Covered Stent 10 mm x 80 mm (80 cm delivery catheter) (flared)
Catalog Number
AVFM10080
Brand Name
COVERA
Version/Model Number
AVFM10080
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
P170042,P170042,P170042
Product Code
PFV
Product Code Name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Public Device Record Key
49879c20-fb94-422e-b319-0ac9846da8d0
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
August 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |
| 3 | A medical device with high risk that requires premarket approval | 174 |