Duns Number:022516829
Device Description: Straight-Tip Arterial Sheath Configuration
Catalog Number
SR-201-NPS
Brand Name
ENROUTE Transcarotid Neuroprotection System
Version/Model Number
SR-201-NPS
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
K153485
Product Code
NTE
Product Code Name
Temporary Carotid Catheter For Embolic Capture
Public Device Record Key
0ad01d09-f87b-427a-914c-25d4b2d776ee
Public Version Date
April 09, 2019
Public Version Number
5
DI Record Publish Date
March 14, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 5 |
3 | A medical device with high risk that requires premarket approval | 18 |