Data / Medical devices / Aspiration Thrombectomy Catheter
Aspiration Thrombectomy Catheter (QEZ): 26 FDA-registered makers in 5 countries
26 establishments in 5 countries are registered with the FDA to make Aspiration Thrombectomy Catheter (product code QEZ, Class 2, 21 CFR 870.5150). 25 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 95 510(k) clearances under this code, the latest on September 3, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QEZ
- Device class
- 2
- Regulation
- 870.5150
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 21 |
| Mexico | 2 |
| Ireland | 1 |
| India | 1 |
| Japan | 1 |
Makers of Aspiration Thrombectomy Catheter
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 |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 5 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 5 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Specification developer | 5 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 5 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 5 | June 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Complaint file establishment, Manufacturer | 4 | November 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | November 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 4 | March 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| Control Medical Technology | South Salt Lake, UT, United States | Specification developer | 3 | May 4, 2020 | 0 | 0 | 0 | api.fda.gov |
| Inquis Medical, Inc. | Menlo Park, CA, United States | Manufacturer | 3 | July 27, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer | 3 | April 23, 2026 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Manufacturer for export | 3 | November 3, 2021 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 3 | December 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer | 3 | December 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Expanse Medical Inc. | Pleasanton, CA, United States | Manufacturer | 2 | March 20, 2026 | 0 | 0 | 0 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Manufacturer | 1 | March 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Complaint file establishment, Specification developer | 1 | March 30, 2009 | 0 | 0 | 0 | api.fda.gov |
| Flowphysix, Inc. | West Lake Hills, TX, United States | Specification developer | 1 | July 14, 2025 | 0 | 0 | 0 | api.fda.gov |
| Meril Life Sciences Pvt. Ltd. | Vapi Gujarat, India | Complaint file establishment, Manufacturer | 1 | April 29, 2019 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 1 | September 3, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Manufacturer | 1 | March 28, 2008 | 0 | 0 | 0 | api.fda.gov |
| Terumo Clinical Supply Co., Ltd. | Kakamigahara Gifu, Japan | Manufacturer | 1 | December 14, 2011 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Contract manufacturer, Manufacturer | 1 | December 22, 2010 | 0 | 0 | 0 | api.fda.gov |
| Vesalio | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | October 24, 2025 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Specification developer | 1 | November 9, 2007 | 0 | 0 | 0 | api.fda.gov |
| Pro-Tech Design & MFG., Inc. | Santa Fe Springs, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 3, 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.