Definition: An Intrasaccular Flow Disruption Device Is Intended For Use To Treat Wide-neck Intracranial Aneurysms In The Neurovasculature Through An Endovascular Approach.
Device Type ID | 3857 |
Device Name | Intrasaccular Flow Disruption Device |
Physical State | A Metal Mesh-like Implant Attached To A Delivery System. |
Technical Method | An Intrasaccular Flow Disruption Device Is A Prescription Use Only Device Used To Treat Wide-neck Intracranial Aneurysms. The Device Is Delivered Into The Neurovasculature With An Endovascular Approach, Implanted Within The Sac Of The Intracranial An |
Target Area | Neurovasculature, Intracranial Aneurysms. |
Review Panel | Neurology |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
Submission Type | PMA |
FDA Device Classification | Class 3 Medical Device |
Product Code | OPR |
GMP Exempt | No |
Summary MR | Ineligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3857 |
Device | Intrasaccular Flow Disruption Device |
Product Code | OPR |
FDA Device Classification | Class 3 Medical Device |