Duns Number:964569052
Device Description: NC TREK NEO™ Coronary Dilatation Catheter 4.50 mm X 15 mm / Rapid-Exchange
Catalog Number
1400450-15
Brand Name
NC TREK NEO™
Version/Model Number
1400450-15
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
LOX
Product Code Name
Catheters, transluminal coronary angioplasty, percutaneous
Public Device Record Key
aef3f8b0-3643-4fe5-9f6f-42614f955c59
Public Version Date
August 23, 2022
Public Version Number
1
DI Record Publish Date
August 15, 2022
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |