Duns Number:135057938
Device Description: Valeo® Biliary Stent 9 mm x 26 mm (80 cm delivery catheter)
Catalog Number
EV09261CD
Brand Name
Valeo® Balloon Expandable Biliary Stent
Version/Model Number
EV09261CD
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
-
Product Code
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
62e83d2b-bd6c-48f3-abac-883f7693ef49
Public Version Date
April 08, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2015
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2835 |
| 3 | A medical device with high risk that requires premarket approval | 190 |