Duns Number:021717889
Device Description: RF Cardiac Ablation Controller
Catalog Number
-
Brand Name
Maestro 4000™ Controller
Version/Model Number
M00440000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
P020025,P920047,P980003
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
f265682e-6741-48f3-a935-6df93cb87797
Public Version Date
June 10, 2022
Public Version Number
5
DI Record Publish Date
January 27, 2015
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 | 536 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8659 |
| 3 | A medical device with high risk that requires premarket approval | 1821 |
| U | Unclassified | 35 |