Duns Number:187129135
Device Description: Embolectomy/thrombectomy balloon catheter
Catalog Number
-
Brand Name
Syntel Thrombectomy Catheter
Version/Model Number
A4545
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
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
df0363cc-c1f8-46be-b27f-199406d9cc43
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
10607915110922
Quantity per Package
5
Contains DI Package
00607915110925
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 499 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 698 |
| 3 | A medical device with high risk that requires premarket approval | 1 |