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 |