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Data / Medical devices / Catheters, Transluminal Coronary Angioplasty, Percutaneous / United States

FDA-registered makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Catheters, Transluminal Coronary Angioplasty, Percutaneous (product code LOX). 12 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Catheters, Transluminal Coronary Angioplasty, Percutaneous
Product code
LOX
Country
United States

Makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Manufacturer for export, Specification developer9March 24, 2022040api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export9March 24, 2022000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Specification developer8June 30, 2022032api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer7June 30, 2022000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer, Manufacturer for export5June 23, 2016020api.fda.gov
Verge Medical Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer5April 2, 2026000api.fda.gov
Hosmed Inc.Doral, FL, United StatesManufacturer, Repackager or relabeler3January 7, 2022000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Specification developer3May 31, 2024000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler1August 13, 2013000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer1January 9, 1990000api.fda.gov
TT Medical Usa, LLCDuxbury, MA, United StatesSpecification developer1June 29, 2023000api.fda.gov
Teleflex LLCBrooklyn Park, MN, United StatesManufacturer1June 23, 2016000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesManufacturer for export0000api.fda.gov
Dynaflex TechnologiesIrvine, CA, United StatesContract manufacturer0000api.fda.gov
Isomedix Operations, Inc.Minneapolis, MN, United StatesManufacturer for export0000api.fda.gov
Lutonix, Inc.Tempe, AZ, United StatesManufacturer for export0000api.fda.gov
Sterigenics U.S., LLCQueensbury, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Sterigenics US LLCLos Angeles, CA, United StatesContract sterilizer, Manufacturer for export0000api.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.