Duns Number:021717889
Device Description: Temperature Ablation Catheter
Catalog Number
M004R4500TH0
Brand Name
IntellaNav™ XP
Version/Model Number
M004R4500TH0
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
P020025,P020025,P020025,P020025,P020025
Product Code
OAD
Product Code Name
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Public Device Record Key
ac5a2a6b-4e79-4006-ad24-66891bd7600d
Public Version Date
October 14, 2021
Public Version Number
6
DI Record Publish Date
March 18, 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 | 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 |