Duns Number:080210058
Device Description: The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and The MegaVac Thrombectomy System is a single-use intravascular mechanical thrombectomy and aspiration system including a ThromboWire containing an embolectomy element. The MegaVac Catheter’s SafeSealTM technology utilizes a distal silicone coated nitinol braid that expands to temporarily occlude antegrade blood flow. The catheter body has inner and outer coaxial shafts that expand the braid, temporarily occluding the vessel and allowing for aspiration. The proximal handle assembly actuates the SafeSeal funnel. The ThromboWire consists of a nitinol embolectomy element that when expanded by the proximal actuation handle, can serve to pull matter towards the MegaVac catheter.
Catalog Number
TWA
Brand Name
ThromboWire
Version/Model Number
ATK
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"
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
K040010
Product Code
DXE
Product Code Name
Catheter, Embolectomy
Public Device Record Key
06e1f660-d6dd-4c47-a5da-61ad3bb5c51f
Public Version Date
October 24, 2022
Public Version Number
6
DI Record Publish Date
April 07, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |