Duns Number:006261481
Device Description: PEN 49314 CARDIOBLATE XL PEN FT
Catalog Number
-
Brand Name
Cardioblate™
Version/Model Number
49314
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
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
K190623
Product Code
OCL
Product Code Name
Surgical Device, For cutting, coagulation, and/or ablation of tissue, including cardiac tissue
Public Device Record Key
2620ede1-a995-40c8-b3e3-536ee12246f5
Public Version Date
June 10, 2022
Public Version Number
3
DI Record Publish Date
September 06, 2019
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 |