Data / Medical devices / Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (POL): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment (product code POL, Class 2, 21 CFR 882.5600). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 18 510(k) clearances under this code, the latest on February 28, 2025, and lists 2 recall events (1 Class I). FDA data exported November 3, 2026.
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- Product code
- POL
- Device class
- 2
- Regulation
- 882.5600
- Medical specialty
- Neurology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| Ireland | 1 |
| China | 1 |
Makers of Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
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 | 6 | March 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 6 | March 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Manufacturer, Specification developer | 5 | March 29, 2023 | 0 | 2 | 1 | api.fda.gov |
| Stryker Neurovascular | Salt Lake City, UT, United States | Manufacturer | 5 | March 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| Phenox Limited | Galway Galway(County), Ireland | Manufacturer | 3 | February 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Gravity Medical Technology | Lake Forest, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeuroVasc Technologies, Inc. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated February 28, 2025. 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.