Data / Medical devices / Device, Vascular, For Promoting Embolization
Device, Vascular, For Promoting Embolization (KRD): 61 FDA-registered makers in 12 countries
61 establishments in 12 countries are registered with the FDA to make Device, Vascular, For Promoting Embolization (product code KRD, Class 2, 21 CFR 870.3300). 41 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 133 510(k) clearances under this code, the latest on October 6, 2026, and lists 13 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- KRD
- Device class
- 2
- Regulation
- 870.3300
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 35 |
| Mexico | 5 |
| China | 5 |
| Ireland | 4 |
| Costa Rica | 3 |
| Canada | 2 |
| Japan | 2 |
| France | 1 |
| Netherlands | 1 |
| Denmark | 1 |
| Vietnam | 1 |
| Switzerland | 1 |
Makers of Device, Vascular, For Promoting 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 |
|---|---|---|---|---|---|---|---|---|
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer, Manufacturer for export, Specification developer | 15 | December 21, 2022 | 0 | 3 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 10 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 8 | August 3, 2016 | 0 | 3 | 0 | api.fda.gov |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Specification developer | 6 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 6 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 5 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 5 | June 24, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 4 | June 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer for export, Specification developer | 4 | June 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Biosphere Medical, S.A. | Roissy Val-d'Oise, France | Contract manufacturer, Manufacturer | 4 | November 21, 2019 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 4 | December 16, 2016 | 0 | 1 | 1 | api.fda.gov |
| Covidien | TIJUANA, B.C. Mexico, Mexico | Manufacturer | 4 | April 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Okami Medical Inc. | Aliso Viejo, CA, United States | Manufacturer | 4 | April 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 4 | June 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Specification developer | 4 | April 22, 2015 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 3 | June 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 3 | February 9, 2021 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 3 | February 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Varian Medical Systems, Inc | Austin, TX, United States | Manufacturer, Repackager or relabeler | 3 | January 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Balt Usa, LLC | Irvine, CA, United States | Complaint file establishment, Manufacturer | 2 | May 30, 2025 | 0 | 2 | 0 | api.fda.gov |
| Shape Memory Medical Inc | San Jose, CA, United States | Manufacturer, Manufacturer for export | 2 | May 23, 2019 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer | 2 | January 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Abk Biomedical | Halifax Nova Scotia, Canada | Complaint file establishment, Manufacturer | 1 | February 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, Netherlands | Manufacturer | 1 | August 7, 2014 | 0 | 0 | 0 | api.fda.gov |
| Canyon Medical Inc. | Nanjing Jiangsu, China | Manufacturer | 1 | September 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Embolization Inc | Boulder, CO, United States | Complaint file establishment, Manufacturer | 1 | May 15, 2025 | 0 | 0 | 0 | api.fda.gov |
| Imbiotechnologies Ltd | Edmonton Alberta, Canada | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | May 10, 2010 | 0 | 0 | 0 | api.fda.gov |
| KA Medical | Arden Hills, MN, United States | Contract manufacturer, Manufacturer | 1 | April 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Perfusion Systems | Minneapolis, MN, United States | Specification developer | 1 | August 11, 1988 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Specification developer | 1 | May 2, 2024 | 0 | 1 | 0 | api.fda.gov |
| Nuvascular Inc. | Irvine, CA, United States | Manufacturer | 1 | July 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Obsidio Inc | Maple Grove, MN, United States | Manufacturer | 1 | October 3, 2024 | 0 | 0 | 0 | api.fda.gov |
| Penumbra, Inc. | Alameda, CA, United States | Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Costa Rica, S.R.L. | Guadalupe Cartago, Costa Rica | Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Salt Lake City, UT, United States | Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Livermore, CA, United States | Manufacturer | 1 | March 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Haowei Medical Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | November 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | October 1, 2021 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 1 | April 17, 2012 | 0 | 1 | 0 | api.fda.gov |
| William Cook Europe Aps | BJAEVERSKOV Sjaelland, Denmark | Complaint file establishment, Manufacturer | 1 | December 18, 2015 | 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 | |
| Boulder Biomed LLC | Boulder, CO, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Minneapolis, MN, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| KANEKA MEDICAL VIETNAM Co.,Ltd. | Ho Chi Minh, Vietnam | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaneka Medix Corporation Kanagawa Plant | Ashigara-Kami-gun Kanagawa, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaneka Corporation Osaka Plant | Settsu-shi Osaka, Japan | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Murray, Inc. | Lake Zurich, IL, 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 | |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Neurotech (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microport Neurotech (shanghai) Co., Ltd. | Shanghai, China | 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 | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Somerset, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics Radiation Technologies, LLC | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Salt Lake City, UT, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 6, 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.