Data / Medical devices / Intracranial Neurovascular Stent
Intracranial Neurovascular Stent (NJE): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Intracranial Neurovascular Stent (product code NJE, Class f). 0 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 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NJE
- Device class
- f
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Ireland | 2 |
| Costa Rica | 1 |
| Switzerland | 1 |
Makers of Intracranial Neurovascular Stent
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cerenovus, Inc. | Raynham, MA, United States | Manufacturer, Manufacturer for export | 0 | 0 | 1 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer for export | 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 | |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 3 | 0 | api.fda.gov | |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 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.