Duns Number:945543689
Device Description: The Optima Coil System is indicated for endovascular embolization of intracranial aneurysm The Optima Coil System is indicated for endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations (AVMs) and arteriovenous fistulae. The Optima Coil System is also indicated for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and for arterial and venous embolization in the peripheral vasculature. The Optima Coil System comprises of implant coil and a pusher assembly. The Optima Coil System is designed fr use with the XCEL Detachment Controller. The Optima coil is detached thermally with the XCEL Detachment Controller.
Catalog Number
N/A
Brand Name
Optima Coil System
Version/Model Number
OPTI0256HSS10
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K172390
Product Code
HCG
Product Code Name
Device, Neurovascular Embolization
Public Device Record Key
ad379cda-f097-4d17-8ab7-3d49720b42e9
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
February 28, 2020
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. | 757 |