Data / Medical devices / Catheter, Percutaneous, Neurovasculature
Catheter, Percutaneous, Neurovasculature (QJP): 52 FDA-registered makers in 11 countries
52 establishments in 11 countries are registered with the FDA to make Catheter, Percutaneous, Neurovasculature (product code QJP, Class 2, 21 CFR 870.1250). 38 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 103 510(k) clearances under this code, the latest on October 9, 2026, and lists 6 recall events (2 Class I). FDA data exported November 2, 2026.
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- Product code
- QJP
- Device class
- 2
- Regulation
- 870.1250
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 30 |
| Ireland | 6 |
| China | 4 |
| Japan | 3 |
| Mexico | 2 |
| Costa Rica | 2 |
| Israel | 1 |
| Switzerland | 1 |
| Thailand | 1 |
| Dominican Republic | 1 |
| Singapore | 1 |
Makers of Catheter, Percutaneous, Neurovasculature
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 |
|---|---|---|---|---|---|---|---|---|
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 10 | October 9, 2026 | 0 | 2 | 0 | api.fda.gov |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Complaint file establishment, Manufacturer | 7 | October 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Asahi Intecc Co., Ltd. | SETO Aichi, Japan | Manufacturer, Specification developer | 6 | May 11, 2026 | 0 | 0 | 0 | api.fda.gov |
| Balt Usa, LLC | Irvine, CA, United States | Complaint file establishment, Manufacturer | 6 | July 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | August 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 5 | October 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Penumbra, Inc. | Alameda, CA, United States | Manufacturer | 5 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Perfuze | Dangan Galway(County), Ireland | Manufacturer | 5 | July 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 5 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Salt Lake City, UT, United States | Manufacturer | 5 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Livermore, CA, United States | Manufacturer | 5 | December 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Route 92 Medical, Head Quarters | San Mateo, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler | 5 | September 16, 2026 | 0 | 1 | 1 | api.fda.gov |
| Route 92 Medical, West Jordan | W Jordan, UT, United States | Manufacturer, Repackager or relabeler | 5 | September 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Complaint file establishment, Manufacturer | 4 | January 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Maduro Medical, Inc. | Los Gatos, CA, United States | Complaint file establishment, Manufacturer | 3 | April 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 3 | January 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Piraeus Medical, Inc. | Maple Grove, MN, United States | Manufacturer | 3 | September 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Heartcare Medical Technology Corporation Limited | Shanghai, China | Manufacturer | 3 | December 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Salt Lake City, UT, United States | Manufacturer | 3 | December 19, 2024 | 0 | 1 | 0 | api.fda.gov |
| Bend It Technologies Ltd. | Petach Tikva Central, Israel | Complaint file establishment, Manufacturer | 2 | December 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | May 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Neuravi Limited | Galway Galway(County), Ireland | Specification developer | 2 | April 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Q'apel Medical, Inc. | Fremont, CA, United States | Manufacturer | 2 | November 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Scientia Vascular | West Valley City, UT, United States | Manufacturer | 2 | December 4, 2024 | 0 | 1 | 0 | api.fda.gov |
| Shanghai Wallaby Medical Technologies CO., Inc. | Shanghai, China | Complaint file establishment, Contract manufacturer, Manufacturer | 2 | August 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 2 | October 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Wallaby Medical | Laguna Hills, CA, United States | Specification developer | 2 | August 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alembic LLC | Mountain View, CA, United States | Complaint file establishment, Manufacturer | 1 | January 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Crossroads Neurovascular | Lake Forest, CA, United States | Specification developer | 1 | May 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shin-Shirakawa Plant | Shirakawa Fukushima, Japan | Manufacturer | 1 | December 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| FUJI SYSTEMS CORPORATION, Shirakawa Plant | Nishi Shirakawa Gun Fukushima, Japan | Manufacturer | 1 | December 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Kaneka Americas Holding Inc | Newark, CA, United States | Complaint file establishment, Specification developer | 1 | January 5, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 1 | February 27, 2020 | 0 | 1 | 1 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 1 | January 2, 2025 | 0 | 0 | 0 | api.fda.gov |
| Sonorous NV, Inc. | Lake Forest, CA, United States | Specification developer | 1 | April 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Zenith Vascular Scitech Limited | Suzhou Jiangsu, China | Manufacturer | 1 | May 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Toro Neurovascular, Inc. | Irvine, CA, United States | Specification developer | 1 | January 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Vesalio | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | January 6, 2026 | 0 | 0 | 0 | api.fda.gov |
| Asahi Intecc (thailand) Co., Ltd. | Amphur Muang Pathumthani Pathum Thani, Thailand | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioseal | Placentia, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brivant, Ltd. | GALWAY Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPE1, LLC DBA Greatbatch Medical | Southwest Ranches, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creganna Medical S. R. L | San Rafael Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerald Medical Services Pte. Ltd | Singapore North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eosolutions, Corp. | Miramar, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ics Medical Devices Ltd | Galway Galway(City), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lake Region Medical | Trenton, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M4D LLC | Lake Forest, CA, 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 | |
| Phenox Limited | Galway Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 9, 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.