Duns Number:021717889
Device Description: Ablation Connection Box (Maestro™)
Catalog Number
-
Brand Name
RHYTHMIA HDx™
Version/Model Number
M004RA6201US0
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,P150005
Product Code
OAD
Product Code Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Public Device Record Key
0489b849-6b0e-4053-aea0-11c8b06e6e7a
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 17, 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 | 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 |