Duns Number:006261481
Device Description: GENERATOR 48021 ATAKR II RF ABLAT 60W US
Catalog Number
-
Brand Name
ATAKR™ II
Version/Model Number
480201
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
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
-
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
P930029
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
336a6a84-2d0a-48b6-ac82-c3c70c950203
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
October 05, 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 | 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 |