Duns Number:149818952
Device Description: Contact Force Ablation Catheter
Catalog Number
PN-004065
Brand Name
TactiCath™
Version/Model Number
Quartz 65
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
-
Product Code
OAE
Product Code Name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Public Device Record Key
7d059fb6-cc0f-4060-8c63-017e59edc532
Public Version Date
January 20, 2022
Public Version Number
4
DI Record Publish Date
November 04, 2014
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 | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |