Duns Number:017535668
Device Description: ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thromb ASPIRE MAX 5 Mechanical Thrombectomy Systems™ for removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
Catalog Number
A5-055
Brand Name
Aspire Max 5 Aspiration Catheter 55cm
Version/Model Number
A5-055
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
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
df3d7d06-0fb2-4e4f-9f23-04af8f6fe967
Public Version Date
August 05, 2022
Public Version Number
6
DI Record Publish Date
August 17, 2017
Package DI Number
B090A50552
Quantity per Package
9
Contains DI Package
B090A50551
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 24 |