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Data / Medical devices / Catheter, Peripheral, Atherectomy / United States

FDA-registered makers of Catheter, Peripheral, Atherectomy in the United States: 17 establishments

17 establishments in the United States are registered with the FDA to make Catheter, Peripheral, Atherectomy (product code MCW). 16 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.

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Device
Catheter, Peripheral, Atherectomy
Product code
MCW
Country
United States

Makers of Catheter, Peripheral, Atherectomy in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cardiovascular Systems IncorporatedSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer14April 27, 20220101api.fda.gov
Cardiovascular Systems IncorporatedHouston, TX, United StatesManufacturer12April 27, 2022000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Manufacturer, Specification developer11March 13, 2025050api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer11August 24, 2021042api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer5September 6, 2022010api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer5September 6, 2022000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer3September 6, 2022000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesSpecification developer2June 1, 2012000api.fda.gov
Philips Image Guided Therapy CorporationPlymouth, MN, United StatesComplaint file establishment, Manufacturer2June 14, 2021000api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer1February 7, 1995000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer1August 27, 2014000api.fda.gov
Cardio Flow, Inc.Blaine, MN, United StatesSpecification developer1September 27, 2023000api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1February 7, 1995000api.fda.gov
Rex Medical LPConshohocken, PA, United StatesSpecification developer1December 15, 2021000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1May 4, 1999000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer1December 19, 2014000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov

Updated November 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.