Duns Number:135057938
Device Description: FLUENCY® PLUS Endovascular Stent Graft 12 mm x 80 mm (80 cm delivery system)
Catalog Number
FEM12080
Brand Name
Fluency® Endovascular Stent Graft
Version/Model Number
FEM12080
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
PFV
Product Code Name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Public Device Record Key
6afd04c6-366f-44af-a4ef-81725ca96f67
Public Version Date
April 08, 2022
Public Version Number
4
DI Record Publish Date
September 19, 2014
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 |