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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

CountryMakers
United States24
Mexico4
China3
Costa Rica2
Ireland2
Japan2
Switzerland1
France1
Vietnam1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer27July 14, 2022000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Manufacturer for export, Specification developer23March 29, 2017010api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer13August 14, 2026011api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer11June 24, 2026050api.fda.gov
Penumbra, Inc.Alameda, CA, United StatesManufacturer10October 25, 2023010api.fda.gov
Penumbra Costa Rica, S.R.L.Guadalupe Cartago, Costa RicaManufacturer10October 25, 2023000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer10October 25, 2023000api.fda.gov
Penumbra Inc.Salt Lake City, UT, United StatesManufacturer10October 25, 2023000api.fda.gov
Penumbra Inc.Livermore, CA, United StatesManufacturer10October 25, 2023000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer7January 27, 2026050api.fda.gov
Stryker NeurovascularCork Munster, IrelandManufacturer7June 24, 2026000api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoManufacturer6July 14, 2022000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer6November 7, 2023000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer6November 7, 2023000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer5November 7, 2023000api.fda.gov
Microport Neurotech (shanghai) Co., Ltd.Shanghai, ChinaManufacturer4May 20, 2026000api.fda.gov
Microport Neurotech (shanghai) Co., Ltd.Shanghai, ChinaManufacturer4May 20, 2026000api.fda.gov
Atrion Medical Products, Inc.Arab, AL, United StatesContract manufacturer, Manufacturer1May 2, 2008000api.fda.gov
Biosphere Medical, S.A.Roissy Val-d'Oise, FranceManufacturer1June 21, 2001000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer1April 16, 2010000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1April 16, 2010000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer1April 16, 2010000api.fda.gov
Cerenovus, Inc.Raynham, MA, United StatesManufacturer1December 7, 2006000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1November 13, 1990010api.fda.gov
KANEKA MEDICAL VIETNAM Co.,Ltd.Ho Chi Minh, VietnamManufacturer1March 26, 2021000api.fda.gov
Kaneka Medix Corporation Kanagawa PlantAshigara-Kami-gun Kanagawa, JapanManufacturer1March 26, 2021000api.fda.gov
Kaneka Corporation Osaka PlantSettsu-shi Osaka, JapanExporter to the US, Specification developer1March 26, 2021000api.fda.gov
Wallaby MedicalLaguna Hills, CA, United StatesSpecification developer1May 4, 2018000api.fda.gov
Amphenol Alden Products CompanyHermosillo Sonora, MexicoContract manufacturer0000api.fda.gov
Benchmark Electronics, Inc.Winona, MN, United StatesContract manufacturer0000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer0000api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
NeuroVasc Technologies, Inc.Irvine, CA, United StatesManufacturer for export0000api.fda.gov
Nipro Vascular Innovations Americas, Inc.Sunnyvale, CA, United StatesManufacturer for export0000api.fda.gov
Scientific Molding Corporation, Ltd. Dba SMC Ltd.Somerset, WI, United StatesContract manufacturer0000api.fda.gov
Shape Memory Medical IncSan Jose, CA, United StatesManufacturer for export0000api.fda.gov
Shanghai Wallaby Medical Technologies CO., Inc.Shanghai, ChinaContract manufacturer0000api.fda.gov
Sterigenics US LLCLos Angeles, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Victorch Meditek, Inc.San Diego, CA, United StatesManufacturer for export0000api.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.