Data / Medical devices / Peripheral Mechanical Thrombectomy With Aspiration / United States
FDA-registered makers of Peripheral Mechanical Thrombectomy With Aspiration in the United States: 35 establishments
35 establishments in the United States are registered with the FDA to make Peripheral Mechanical Thrombectomy With Aspiration (product code QEW). 23 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Peripheral Mechanical Thrombectomy With Aspiration
- Product code
- QEW
- Country
- United States
Makers of Peripheral Mechanical Thrombectomy With Aspiration in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Penumbra, Inc. | Alameda, CA, United States | Manufacturer | 27 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 27 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Salt Lake City, UT, United States | Manufacturer | 27 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Livermore, CA, United States | Manufacturer | 27 | October 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Inari Medical, Inc. | Irvine, CA, United States | Manufacturer | 18 | October 29, 2025 | 0 | 2 | 1 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 5 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | May 29, 2024 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Specification developer | 4 | March 28, 2024 | 0 | 0 | 0 | api.fda.gov |
| Contego Medical, Inc | Raleigh, NC, United States | Complaint file establishment, Specification developer | 4 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | August 28, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 3 | September 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 3 | September 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Endovascular Engineering, Inc. | Menlo Park, CA, United States | Complaint file establishment, Manufacturer | 3 | September 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Endologix LLC | Santa Rosa, CA, United States | Complaint file establishment, Specification developer | 3 | September 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Ichor Vascular Inc | Brecksville, OH, United States | Manufacturer, Specification developer | 2 | July 18, 2024 | 0 | 0 | 0 | api.fda.gov |
| Inquis Medical, Inc. | Menlo Park, CA, United States | Manufacturer | 2 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| Expanse Medical Inc. | Pleasanton, CA, United States | Manufacturer | 1 | April 19, 2024 | 0 | 0 | 0 | api.fda.gov |
| Intervene Inc | Redwood City, CA, United States | Manufacturer | 1 | October 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Innova Vascular, Inc. | Irvine, CA, United States | Manufacturer | 1 | June 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Surmodics, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Contract manufacturer, Repackager or relabeler | 1 | December 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | October 24, 2001 | 0 | 0 | 0 | api.fda.gov |
| Vesalio | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Verge Medical Inc. | Campbell, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 1 | January 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cathx Medical Inc | Arden Hills, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cathx Medical Inc | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Santa Clara, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Excel Medical Products, Inc. | Wixom, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Murray, Inc. | Lake Zurich, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Protexa Endovascular | Grand Junction, CO, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scientific Molding Corporation, Ltd. Dba SMC Ltd. | Santa Rosa, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.