Duns Number:021717889
Device Description: Temperature Ablation Catheter
Catalog Number
M004P5031THK20
Brand Name
Blazer Prime® HTD
Version/Model Number
M004P5031THK20
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
P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047,P920047
Product Code
LPB
Product Code Name
Cardiac ablation percutaneous catheter
Public Device Record Key
b799b722-f998-4507-9390-0f91439dd508
Public Version Date
September 16, 2021
Public Version Number
6
DI Record Publish Date
September 24, 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 | 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 |