Data / Medical devices / Catheter, Coronary, Atherectomy

Catheter, Coronary, Atherectomy (MCX): 17 FDA-registered makers in 8 countries

Name: FDA-registered makers of Catheter, Coronary, Atherectomy
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

17 establishments in 8 countries are registered with the FDA to make Catheter, Coronary, Atherectomy (product code MCX, Class 3). 11 of them have a 510(k) clearance or PMA approval on file and 2 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 12 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code: MCX
Device class: 3
Medical specialty: Unknown

Makers by country

Country	Makers
United States	9
Ireland	2
Costa Rica	1
Turkey	1
Canada	1
Sweden	1
Austria	1
Mexico	1

Makers of Catheter, Coronary, Atherectomy

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	PMA approvals	Recall events	Class I	Source
Boston Scientific Corporation	Maple Grove, MN, United States	Manufacturer, Specification developer	2	3	1	api.fda.gov
Boston Scientific Corporation	Saint Paul, MN, United States	Complaint file establishment, Manufacturer	2	0	0	api.fda.gov
Boston Scientific Corporation	Coventry, RI, United States	Manufacturer	2	0	0	api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	Quincy, MA, United States	Manufacturer	1	0	0	api.fda.gov
Boston Scientific Corporation	El Coyol Alajuela, Costa Rica	Manufacturer	1	0	0	api.fda.gov
Boston Scientific Corporation	Dorado, PR, United States	Manufacturer	1	0	0	api.fda.gov
Boston Scientific Limited	GALWAY Galway(County), Ireland	Manufacturer	1	0	0	api.fda.gov
Boston Scientific Limited	CORK Munster, Ireland	Manufacturer	1	0	0	api.fda.gov
Cardiovascular Systems Incorporated	Houston, TX, United States	Manufacturer	1	0	0	api.fda.gov
Cardiovascular Systems Incorporated	Saint Paul, MN, United States	Manufacturer	1	4	1	api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited Sirketi	Istanbul, Turkey	Exporter to the US, Manufacturer	1	0	0	api.fda.gov
Creation Technologies Ltd	Burnaby British Columbia, Canada	Contract manufacturer	0	0	0	api.fda.gov
Fresenius Kabi AB	Uppsala, Sweden	Contract manufacturer, Contract sterilizer	0	0	0	api.fda.gov
Fresenius Kabi Austria GMBH	GRAZ Steiermark, Austria	Contract manufacturer, Contract sterilizer	0	0	0	api.fda.gov
Lake Region Medical	Chaska, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
Minnetronix, Inc.	Saint Paul, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, Mexico	Contract manufacturer	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.