Duns Number:006261481
Device Description: STENT GRAFT VAMF3636C200TU VALCAP FREFL
Catalog Number
-
Brand Name
VALIANT® Captivia
Version/Model Number
VAMF3636C200TU
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 24, 2018
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
P100040
Product Code
MIH
Product Code Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Public Device Record Key
079e144a-2985-4b5e-b7eb-118716a1786c
Public Version Date
December 21, 2020
Public Version Number
5
DI Record Publish Date
September 23, 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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |