Duns Number:017535668
Device Description: The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indi The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.
Catalog Number
A11-060
Brand Name
Control 11F Mechanical Thrombectomy System, 60cm
Version/Model Number
A11-060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
QEZ
Product Code Name
Aspiration Thrombectomy Catheter
Public Device Record Key
97b4531a-3a1d-4bc5-a87c-71c3f72e02d6
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
June 29, 2022
Package DI Number
B090A110601
Quantity per Package
1
Contains DI Package
B090A110600
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shelf Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |