Duns Number:844782318
Device Description: Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic Bileaflet mechanical heart valve attached to a vascular prosthesis implanted in the aortic position
Catalog Number
ONXAAP-19
Brand Name
On-X Ascending Aortic Prosthesis
Version/Model Number
ONXAAP-19
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"
-
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
P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037,P000037
Product Code
LWQ
Product Code Name
Heart-Valve, Mechanical
Public Device Record Key
55d91e92-45bf-4f73-b7a1-3f1728af29dd
Public Version Date
February 05, 2021
Public Version Number
6
DI Record Publish Date
September 12, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 39 |
| 3 | A medical device with high risk that requires premarket approval | 39 |