Duns Number:308951313
Device Description: The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of The D*Clot® HD Rotational Thrombectomy Catheter is indicated for mechanical declotting of native vessel dialysis fistulae and synthetic dialysis access grafts
Catalog Number
T10106065
Brand Name
D*Clot® HD Rotational Thrombectomy System
Version/Model Number
D*Clot® HD 6Fx65CM
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
K021641,K021641
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
9ffa0a90-2617-4313-9674-8f55345172a1
Public Version Date
March 24, 2020
Public Version Number
1
DI Record Publish Date
March 16, 2020
Package DI Number
05711055004336
Quantity per Package
1
Contains DI Package
15711055004333
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelfbox
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 90 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 152 |