Duns Number:135057938
Device Description: FLAIR® Endovascular Stent Graft 8 mm x 70 mm (80 cm delivery catheter)(straight)
Catalog Number
FAS08070
Brand Name
Flair® Endovascular Stent Graft
Version/Model Number
FAS08070
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 10, 2022
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"
-
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
P060002,P060002,P060002,P060002,P060002,P060002,P060002,P060002
Product Code
PFV
Product Code Name
System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
Public Device Record Key
a21766bd-ea59-4a00-8ea8-fcfb42784986
Public Version Date
June 16, 2022
Public Version Number
6
DI Record Publish Date
September 19, 2014
Package DI Number
14049519009008
Quantity per Package
1
Contains DI Package
04049519009001
Package Discontinue Date
May 10, 2022
Package Status
Not in Commercial Distribution
Package Type
Other
| 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 |