Duns Number:058614483
Device Description: Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x Endovenous Radiofrequency Ablation (RFA) Catheter,7 cm Heating Element,7 Fr/Ch (2.3 mm) x 60 cm
Catalog Number
-
Brand Name
ClosureFast
Version/Model Number
CF7-7-60
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"
Yes
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
K111887
Product Code
GEI
Product Code Name
ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
Public Device Record Key
3e76c370-b12b-48eb-b6af-9825a8d8a703
Public Version Date
July 02, 2021
Public Version Number
8
DI Record Publish Date
September 24, 2016
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 | 132 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8540 |
| 3 | A medical device with high risk that requires premarket approval | 202 |
| U | Unclassified | 40 |