Duns Number:017535668
Device Description: ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive U ASPIRE RX-LP6 Mechanical Thrombectomy System™ and the ASPIRE Mechanical Aspirator™ Drive Unit / Pump for removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
Catalog Number
ARX-LP6
Brand Name
Aspire RX-LP6 Aspiration Catheter 136
Version/Model Number
ARX-LP6
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
K131998,K131998,K131998
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
7401fd76-daa3-455a-ae69-d3ec0299077b
Public Version Date
June 10, 2022
Public Version Number
7
DI Record Publish Date
August 17, 2017
Package DI Number
B090ARXLP62
Quantity per Package
9
Contains DI Package
B090ARXLP61
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 |