Data / Medical devices / Mechanical Thrombolysis Catheter / United States
FDA-registered makers of Mechanical Thrombolysis Catheter in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Mechanical Thrombolysis Catheter (product code QEY). 8 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- Device
- Mechanical Thrombolysis Catheter
- Product code
- QEY
- Country
- United States
Makers of Mechanical Thrombolysis Catheter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 7 | April 20, 2022 | 0 | 2 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 7 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | April 20, 2022 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 4 | September 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 4 | September 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer | 4 | October 31, 2016 | 0 | 1 | 0 | api.fda.gov |
| Thrombolex, Inc. | New Britain, PA, United States | Specification developer | 3 | July 3, 2023 | 0 | 0 | 0 | api.fda.gov |
| Liquet Medical Inc. | Glen Allen, VA, United States | Specification developer | 1 | November 25, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tiercel Surgical | New Britain, PA, 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.