Data / Medical devices / Wire, Guide, Catheter / United States
FDA-registered makers of Wire, Guide, Catheter in the United States: 87 establishments
87 establishments in the United States are registered with the FDA to make Wire, Guide, Catheter (product code DQX). 69 have a 510(k) clearance or PMA approval on file and 15 have a recall event. FDA data exported November 3, 2026.
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- Device
- Wire, Guide, Catheter
- Product code
- DQX
- Country
- United States
Makers of Wire, Guide, Catheter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Specification developer | 42 | November 6, 2024 | 0 | 2 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 34 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer, Specification developer | 32 | December 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 26 | September 26, 2018 | 0 | 0 | 0 | api.fda.gov |
| Lake Region Medical | Chaska, MN, United States | Contract manufacturer, Manufacturer, Specification developer | 23 | December 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 22 | January 31, 2026 | 0 | 3 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 20 | July 22, 2019 | 0 | 9 | 2 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 15 | October 11, 2023 | 0 | 1 | 0 | api.fda.gov |
| Abbott Vascular | Barceloneta, PR, United States | Manufacturer | 9 | November 6, 2024 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer, Repackager or relabeler, Specification developer | 9 | May 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer | 8 | March 25, 2009 | 0 | 1 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 7 | March 1, 2004 | 0 | 9 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 7 | March 13, 2006 | 0 | 3 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 7 | March 1, 2004 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Specification developer | 7 | July 13, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 6 | August 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Raynham, MA, United States | Manufacturer | 6 | August 14, 2012 | 0 | 0 | 0 | api.fda.gov |
| Heraeus Medical Components, LLC | Saint Paul, MN, United States | Complaint file establishment, Contract manufacturer, Specification developer | 6 | February 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 6 | July 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 6 | July 21, 2020 | 0 | 0 | 0 | api.fda.gov |
| Arrow International LLC (subsidiary of Teleflex Incorporated) | Morrisville, NC, United States | Complaint file establishment, Specification developer | 4 | September 18, 2024 | 0 | 3 | 2 | api.fda.gov |
| Cook Medical LLC | Bloomington, IN, United States | Complaint file establishment, Contract manufacturer | 4 | November 9, 2025 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Repackager or relabeler, Specification developer | 4 | March 11, 2015 | 0 | 1 | 1 | api.fda.gov |
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Specification developer | 4 | June 13, 2025 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical, Cardiology Division, Inc. | Plymouth, MN, United States | Complaint file establishment, Specification developer | 4 | March 1, 2000 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Contract manufacturer, Manufacturer, Repackager or relabeler | 3 | December 8, 2016 | 0 | 3 | 1 | api.fda.gov |
| Abbott Medical | Plymouth, MN, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 3 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer, Specification developer | 3 | October 3, 2025 | 0 | 0 | 0 | api.fda.gov |
| Galt Medical Corp. | Garland, TX, United States | Contract manufacturer, Manufacturer | 3 | April 23, 2015 | 0 | 2 | 0 | api.fda.gov |
| Scientia Vascular | West Valley City, UT, United States | Manufacturer | 3 | July 29, 2020 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Salt Lake City, UT, United States | Manufacturer | 3 | March 13, 2006 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 3 | April 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | New Britain, CT, United States | Contract manufacturer, Manufacturer | 2 | July 20, 2012 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Manufacturer, Repackager or relabeler | 2 | March 15, 1994 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 2 | January 28, 1997 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | November 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Williamston, MI, United States | Specification developer | 2 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Guidewire Technologies, Inc. | Salem, NH, United States | Contract manufacturer, Manufacturer | 2 | July 31, 1990 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 2 | December 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | February 24, 2010 | 0 | 0 | 0 | api.fda.gov |
| Volcano Corporation | Rancho Cordova, CA, United States | Manufacturer | 2 | September 28, 2020 | 0 | 2 | 0 | api.fda.gov |
| Abbott Medical | Minnetonka, MN, United States | Manufacturer | 1 | May 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Sylmar, CA, United States | Specification developer | 1 | May 8, 2012 | 0 | 0 | 0 | api.fda.gov |
| Acme-Monaco Corp. | Presque Isle, ME, United States | Contract manufacturer, Manufacturer | 1 | August 19, 1992 | 0 | 0 | 0 | api.fda.gov |
| Atricure, Inc. | Mason, OH, United States | Complaint file establishment, Manufacturer | 1 | August 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| Avid Medical, Inc. A Medical Action Ind. Company 305 | Toano, VA, United States | Manufacturer, Repackager or relabeler | 1 | October 9, 1997 | 0 | 0 | 0 | api.fda.gov |
| AtriCure, Inc. | Pleasanton, CA, United States | Specification developer | 1 | August 11, 2008 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer, Repackager or relabeler | 1 | January 28, 1997 | 0 | 0 | 0 | api.fda.gov |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer, Manufacturer | 1 | April 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 1 | November 8, 2012 | 0 | 11 | 0 | api.fda.gov |
| C2Dx, Inc. | Schoolcraft, MI, United States | Complaint file establishment, Manufacturer | 1 | March 9, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cardio Flow, Inc. | Blaine, MN, United States | Specification developer | 1 | March 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Centurion Medical Products, LP | Howell, MI, United States | Manufacturer | 1 | May 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Confluent Medical Technologies, Inc | Fremont, CA, United States | Specification developer | 1 | August 28, 2001 | 0 | 1 | 1 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 1 | June 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Gyrus ACMI, Inc. | Brooklyn Park, MN, United States | Complaint file establishment, Specification developer | 1 | December 14, 2007 | 0 | 0 | 0 | api.fda.gov |
| Insitu Technologies, Inc. | Saint Paul, MN, United States | Specification developer | 1 | June 7, 2006 | 0 | 0 | 0 | api.fda.gov |
| Medtronic, Inc. | Mounds View, MN, United States | Specification developer | 1 | March 11, 2015 | 0 | 2 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 1 | June 14, 1977 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Santa Rosa, CA, United States | Specification developer | 1 | October 24, 2023 | 0 | 0 | 0 | api.fda.gov |
| Mermaid Medical A/S (FL Site) | University Park, FL, United States | Complaint file establishment, Specification developer | 1 | March 31, 1994 | 0 | 0 | 0 | api.fda.gov |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 1 | December 10, 1992 | 0 | 0 | 0 | api.fda.gov |
| Solo Pace Inc | Brooklyn Park, MN, United States | Specification developer | 1 | January 9, 2026 | 0 | 0 | 0 | api.fda.gov |
| Spectranetics Corp. | Colorado Springs, CO, United States | Complaint file establishment, Specification developer | 1 | February 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Stereotaxis, Inc. | Saint Louis, MO, United States | Manufacturer | 1 | August 24, 2007 | 0 | 0 | 0 | api.fda.gov |
| Sureax Medical, Corporation | San Diego, CA, United States | Complaint file establishment, Repackager or relabeler, Reprocessor, Specification developer | 1 | October 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 1 | July 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Manufacturer | 1 | July 18, 2002 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 1 | December 10, 2014 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arbor Endovascular | San Jose, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Argon Medical Devices, Inc. | Wheeling, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Westford, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Balt Usa, LLC | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Centerline Biomedical | Cleveland, OH, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| I-Tek Medical, Inc. | White Bear Lake, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NeedleTech Products, Inc. | N Attleboro, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Piraeus Medical, Inc. | Maple Grove, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical, Atrial Fibrillation Division, Inc. | Saint Paul, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zurich Medical Inc | Plymouth, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.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.