Duns Number:532702946
Device Description: The Comaneci is intended for use in the neurovasculature to assist in the coil embolizatio The Comaneci is intended for use in the neurovasculature to assist in the coil embolization of wide-necked intracranial aneurysms under fluoroscopic guidance. The Comaneci is comprised of a collapsible, fully retrievable, fine wire construction mounted on a wire shaft that expands to comply with the vessel diameter. It is delivered through a neurovascular microcatheter. The Comaneci is provided with a 3.5 French (F) peelable loading sheath.
Catalog Number
-
Brand Name
Comaneci
Version/Model Number
ANPP7177
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"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
DEN170064,DEN170064,DEN170064,DEN170064
Product Code
PUU
Product Code Name
Temporary Coil Embolization Assist Device
Public Device Record Key
a38456ef-861a-40cc-9136-a4860b5fc302
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
May 17, 2019
Package DI Number
17290015107133
Quantity per Package
3
Contains DI Package
07290015107136
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |