Duns Number:149818952
Device Description: Ablation Catheter
Catalog Number
A-FASE-FF
Brand Name
FlexAbility™
Version/Model Number
A-FASE-FF
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
P110016,P110016,P110016
Product Code
OAD
Product Code Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Public Device Record Key
28b8c7aa-21da-48ad-92b8-f319ba405137
Public Version Date
November 16, 2020
Public Version Number
4
DI Record Publish Date
February 22, 2017
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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |