Data / Medical devices / Catheter, Coronary, Atherectomy / United States
FDA-registered makers of Catheter, Coronary, Atherectomy in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Catheter, Coronary, Atherectomy (product code MCX). 7 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
- Catheter, Coronary, Atherectomy
- Product code
- MCX
- Country
- United States
Makers of Catheter, Coronary, Atherectomy 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 | Manufacturer, Specification developer | 0 | 2 | 3 | 1 | api.fda.gov | |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardiovascular Systems Incorporated | Houston, TX, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardiovascular Systems Incorporated | Saint Paul, MN, United States | Manufacturer | 0 | 1 | 4 | 1 | api.fda.gov | |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnetronix, Inc. | Saint Paul, MN, 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.