Data / Medical devices / Device, Neurovascular Embolization
Device, Neurovascular Embolization (HCG): 40 FDA-registered makers in 9 countries
40 establishments in 9 countries are registered with the FDA to make Device, Neurovascular Embolization (product code HCG, Class 2, 21 CFR 882.5950). 28 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 187 510(k) clearances under this code, the latest on August 14, 2026, and lists 20 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- HCG
- Device class
- 2
- Regulation
- 882.5950
- Medical specialty
- Neurology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 24 |
| Mexico | 4 |
| China | 3 |
| Costa Rica | 2 |
| Ireland | 2 |
| Japan | 2 |
| Switzerland | 1 |
| France | 1 |
| Vietnam | 1 |
Makers of Device, Neurovascular Embolization
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 |
|---|---|---|---|---|---|---|---|---|
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 27 | July 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 23 | March 29, 2017 | 0 | 1 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 13 | August 14, 2026 | 0 | 1 | 1 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 11 | June 24, 2026 | 0 | 5 | 0 | api.fda.gov |
| Penumbra, Inc. | Alameda, CA, United States | Manufacturer | 10 | October 25, 2023 | 0 | 1 | 0 | api.fda.gov |
| Penumbra Costa Rica, S.R.L. | Guadalupe Cartago, Costa Rica | Manufacturer | 10 | October 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 10 | October 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Salt Lake City, UT, United States | Manufacturer | 10 | October 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Livermore, CA, United States | Manufacturer | 10 | October 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Balt Usa, LLC | Irvine, CA, United States | Complaint file establishment, Manufacturer | 7 | January 27, 2026 | 0 | 5 | 0 | api.fda.gov |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 7 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Manufacturer | 6 | July 14, 2022 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 6 | November 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 6 | November 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 5 | November 7, 2023 | 0 | 0 | 0 | api.fda.gov |
| Microport Neurotech (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 4 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Microport Neurotech (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 4 | May 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Atrion Medical Products, Inc. | Arab, AL, United States | Contract manufacturer, Manufacturer | 1 | May 2, 2008 | 0 | 0 | 0 | api.fda.gov |
| Biosphere Medical, S.A. | Roissy Val-d'Oise, France | Manufacturer | 1 | June 21, 2001 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 1 | April 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 1 | April 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 1 | April 16, 2010 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Raynham, MA, United States | Manufacturer | 1 | December 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 1 | November 13, 1990 | 0 | 1 | 0 | api.fda.gov |
| KANEKA MEDICAL VIETNAM Co.,Ltd. | Ho Chi Minh, Vietnam | Manufacturer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kaneka Medix Corporation Kanagawa Plant | Ashigara-Kami-gun Kanagawa, Japan | Manufacturer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Kaneka Corporation Osaka Plant | Settsu-shi Osaka, Japan | Exporter to the US, Specification developer | 1 | March 26, 2021 | 0 | 0 | 0 | api.fda.gov |
| Wallaby Medical | Laguna Hills, CA, United States | Specification developer | 1 | May 4, 2018 | 0 | 0 | 0 | api.fda.gov |
| Amphenol Alden Products Company | Hermosillo Sonora, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Benchmark Electronics, Inc. | Winona, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 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 | |
| NPA de Mexico S.de R.L. de C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeuroVasc Technologies, Inc. | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro Vascular Innovations Americas, Inc. | Sunnyvale, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shape Memory Medical Inc | San Jose, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Wallaby Medical Technologies CO., Inc. | Shanghai, China | 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 | |
| Victorch Meditek, Inc. | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 14, 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.