OUT · Intracranial Aneurysm Flow Diverter
· Class 3
Overview
| Product Code | OUT |
|---|---|
| Device Name | Intracranial Aneurysm Flow Diverter |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
Identification
Treatment of wide-necked and larger or giant intracranial aneurysms.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P180027 | Flow Re-Direction Endoluminal Device (FRED®) System | MicroVention, Inc. | Dec 16, 2019 | APPR |
| P170024 | Surpass Streamline Flow Diverter | Stryker Neurovascular | Jul 13, 2018 | APPR |
| P100018 | PIPELINE EMBOLIZATION DEVICE | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | Apr 6, 2011 | APPR |
Top Applicants
- Micro Therapeutics, Inc. d/b/a ev3 Neurovascular — 1 clearance
- MicroVention, Inc. — 1 clearance
- Stryker Neurovascular — 1 clearance
