Data / Medical devices / Intracranial Aneurysm Flow Diverter
Intracranial Aneurysm Flow Diverter (OUT): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Intracranial Aneurysm Flow Diverter (product code OUT, Class 3). 5 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 10 recall events (4 Class I). FDA data exported November 2, 2026.
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- Product code
- OUT
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Ireland | 1 |
| Costa Rica | 1 |
Makers of Intracranial Aneurysm Flow Diverter
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 3 | 1 | api.fda.gov | |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 0 | 1 | 2 | 0 | api.fda.gov | |
| Stryker Neurovascular | Fremont, CA, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Galaxy Therapeutics Inc. | Milpitas, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroVention Costa Rica S.R.L. | . Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics US LLC | Los Angeles, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.