Skip to the page

Data / Medical devices / Wire, Guide, Catheter

Wire, Guide, Catheter (DQX): 159 FDA-registered makers in 23 countries

159 establishments in 23 countries are registered with the FDA to make Wire, Guide, Catheter (product code DQX, Class 2, 21 CFR 870.1330). 108 of them have a 510(k) clearance or PMA approval on file and 15 have a recall event. The FDA has issued 769 510(k) clearances under this code, the latest on October 16, 2026, and lists 73 recall events (9 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Product code
DQX
Device class
2
Regulation
870.1330
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States87
Japan11
Mexico11
Costa Rica9
China7
Ireland6
Canada3
Germany3
Switzerland3
Czechia2
Denmark2
Israel2
Dominican Republic2
Netherlands2
Malaysia1
Singapore1
Taiwan1
India1
Thailand1
Vietnam1
France1
Honduras1
Philippines1

Makers of Wire, Guide, Catheter

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Asahi Intecc Co., Ltd.SETO Aichi, JapanManufacturer, Specification developer49April 2, 2025000api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export, Specification developer42November 6, 2024020api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer34November 6, 2024000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Specification developer32December 19, 2022000api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaManufacturer, Specification developer26September 26, 2018000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer26September 26, 2018000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer23September 26, 2018000api.fda.gov
Lake Region MedicalChaska, MN, United StatesContract manufacturer, Manufacturer, Specification developer23December 6, 2024000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler22January 31, 2026030api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export20July 22, 2019092api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler16September 18, 2024000api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer15October 11, 2023010api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanContract manufacturer, Manufacturer14November 26, 2024000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer12September 26, 2018000api.fda.gov
Brivant, Ltd.GALWAY Galway(County), IrelandComplaint file establishment, Contract manufacturer, Manufacturer11March 19, 2026000api.fda.gov
Abbott VascularBarceloneta, PR, United StatesManufacturer9November 6, 2024000api.fda.gov
Arrow International C.R. a.s.ZDAR NAD SAZAVOU Vysocina, CzechiaExporter to the US, Manufacturer, Repackager or relabeler9February 26, 2008000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer, Repackager or relabeler, Specification developer9May 5, 2023000api.fda.gov
Filmecc Co., Ltd.Seto-shi Aichi, JapanComplaint file establishment, Manufacturer, Specification developer8September 3, 2026000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Reprocessor, Specification developer8March 25, 2009010api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer7March 1, 2004090api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer7March 13, 2006030api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler7March 1, 2004000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesSpecification developer7July 13, 2012000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer6August 14, 2012000api.fda.gov
Cerenovus, Inc.Raynham, MA, United StatesManufacturer6August 14, 2012000api.fda.gov
Heraeus Medical Components, LLCSaint Paul, MN, United StatesComplaint file establishment, Contract manufacturer, Specification developer6February 20, 2015000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer6July 21, 2020000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer6July 21, 2020000api.fda.gov
FMD. Co., Ltd.Komaki Aichi, JapanManufacturer, Specification developer5June 13, 2024000api.fda.gov
Opsens Inc.Quebec City, CanadaManufacturer5May 24, 2024000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaExporter to the US, Manufacturer4August 15, 1993000api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesComplaint file establishment, Specification developer4September 18, 2024032api.fda.gov
Cook Medical LLCBloomington, IN, United StatesComplaint file establishment, Contract manufacturer4November 9, 2025000api.fda.gov
Medtronic VascularDanvers, MA, United StatesRepackager or relabeler, Specification developer4March 11, 2015011api.fda.gov
Merit Medical Ireland, LtdGalway Galway(County), IrelandContract manufacturer, Repackager or relabeler4March 31, 1994000api.fda.gov
Medtronic Heart Valves DivisionSanta Ana, CA, United StatesSpecification developer4June 13, 2025000api.fda.gov
St. Jude Medical, Cardiology Division, Inc.Plymouth, MN, United StatesComplaint file establishment, Specification developer4March 1, 2000000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler3December 8, 2016031api.fda.gov
Abbott MedicalPlymouth, MN, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer3October 3, 2025000api.fda.gov
Abbott MedicalSaint Paul, MN, United StatesManufacturer, Specification developer3October 3, 2025000api.fda.gov
Boston Scientific CorporationMississauga Ontario, CanadaManufacturer, Specification developer3December 19, 2022000api.fda.gov
Boston Scientific Medical Device (Malaysia) SDN BHDTaman Perindustrian Batu Kawan Pulau Pinang, MalaysiaManufacturer3April 12, 2018000api.fda.gov
Galt Medical Corp.Garland, TX, United StatesContract manufacturer, Manufacturer3April 23, 2015020api.fda.gov
Lake Region Medical LimitedNEW ROSS Wexford, IrelandContract manufacturer, Manufacturer3December 17, 2014000api.fda.gov
Scientia VascularWest Valley City, UT, United StatesManufacturer3July 29, 2020000api.fda.gov
Stryker NeurovascularSalt Lake City, UT, United StatesManufacturer3March 13, 2006000api.fda.gov
Volcano CorporationSan Diego, CA, United StatesComplaint file establishment, Specification developer3April 15, 2021000api.fda.gov
Acme-Monaco Corp.New Britain, CT, United StatesContract manufacturer, Manufacturer2July 20, 2012000api.fda.gov
Allwell Medical CorporationRaleigh, NC, United StatesManufacturer, Repackager or relabeler2March 15, 1994000api.fda.gov
B. Braun Medical Inc.Bethlehem, PA, United StatesSpecification developer2January 28, 1997000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2November 8, 2012000api.fda.gov
Centurion Medical Products, LPWilliamston, MI, United StatesSpecification developer2May 17, 2022000api.fda.gov
FMD Co., Ltd. Okinawa FactoryUruma Okinawa, JapanContract manufacturer, Manufacturer2June 13, 2024000api.fda.gov
Guidewire Technologies, Inc.Salem, NH, United StatesContract manufacturer, Manufacturer2July 31, 1990000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer, Repackager or relabeler2December 10, 1992000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer, Repackager or relabeler, Specification developer2February 24, 2010000api.fda.gov
Sunny Medical Device (shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaManufacturer2October 13, 2016000api.fda.gov
Volcano CorporationRancho Cordova, CA, United StatesManufacturer2September 28, 2020020api.fda.gov
Volcano Corporation by Volcarica S.R.L.Coyol Alajuela, Costa RicaManufacturer2September 28, 2020000api.fda.gov
William Cook Europe ApsBJAEVERSKOV Sjaelland, DenmarkComplaint file establishment, Manufacturer2November 9, 2025000api.fda.gov
Abbott MedicalMinnetonka, MN, United StatesManufacturer1May 8, 2012000api.fda.gov
Abbott MedicalSylmar, CA, United StatesSpecification developer1May 8, 2012000api.fda.gov
Acme-Monaco Corp.Presque Isle, ME, United StatesContract manufacturer, Manufacturer1August 19, 1992000api.fda.gov
Atricure, Inc.Mason, OH, United StatesComplaint file establishment, Manufacturer1August 11, 2008000api.fda.gov
Avid Medical, Inc. A Medical Action Ind. Company 305Toano, VA, United StatesManufacturer, Repackager or relabeler1October 9, 1997000api.fda.gov
Acme Monaco Asia Pte. Ltd.Singapore Central Singapore, SingaporeContract manufacturer, Manufacturer1August 19, 1992000api.fda.gov
AtriCure, Inc.Pleasanton, CA, United StatesSpecification developer1August 11, 2008000api.fda.gov
B. Braun Us Device Manufacturing LLCAllentown, PA, United StatesContract manufacturer, Repackager or relabeler1January 28, 1997000api.fda.gov
Baylis Medical Technologies Inc.Mississauga Ontario, CanadaComplaint file establishment, Manufacturer1March 7, 2002000api.fda.gov
Beijing Bywave Sensing Medical Technology Co., Ltd.Beijing, ChinaManufacturer1February 18, 2021000api.fda.gov
BIOMERICS Advanced CatheterBrooklyn Park, MN, United StatesContract manufacturer, Manufacturer1April 28, 2023000api.fda.gov
Biotronik Se & Co. KGBerlin, GermanyExporter to the US, Manufacturer1December 4, 2008000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Specification developer1November 8, 20120110api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer1November 9, 2017000api.fda.gov
C2Dx, Inc.Schoolcraft, MI, United StatesComplaint file establishment, Manufacturer1March 9, 2018000api.fda.gov
Cardio Flow, Inc.Blaine, MN, United StatesSpecification developer1March 18, 2022000api.fda.gov
Centurion Medical Products, LPHowell, MI, United StatesManufacturer1May 17, 2022000api.fda.gov
Confluent Medical Technologies, IncFremont, CA, United StatesSpecification developer1August 28, 2001011api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoManufacturer1March 11, 1996000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer1June 14, 1977000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer1June 14, 1977000api.fda.gov
Embrace Medical Ltd.Tel Aviv, IsraelComplaint file establishment, Specification developer1July 14, 2023000api.fda.gov
Flat Medical Co., Ltd.Taipei, TaiwanComplaint file establishment, Manufacturer, Specification developer1September 21, 2022000api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Specification developer1December 14, 2007000api.fda.gov
Insitu Technologies, Inc.Saint Paul, MN, United StatesSpecification developer1June 7, 2006000api.fda.gov
Lepu Medical Technology (beijing) Co., LtdBeijing, ChinaManufacturer1January 21, 2015000api.fda.gov
Medtronic, Inc.Mounds View, MN, United StatesSpecification developer1March 11, 2015020api.fda.gov
Mermaid Medical A/SStenloese Hovedstaden, DenmarkManufacturer1March 31, 1994000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer1June 14, 1977000api.fda.gov
Medtronic VascularSanta Rosa, CA, United StatesSpecification developer1October 24, 2023000api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.Tijuana Baja California, MexicoManufacturer1July 13, 2026000api.fda.gov
Mermaid Medical A/S (FL Site)University Park, FL, United StatesComplaint file establishment, Specification developer1March 31, 1994000api.fda.gov
Nano4imaging GMBHDuesseldorf North Rhine-Westphalia, GermanyManufacturer1March 6, 2026000api.fda.gov
Nipro Medical Industries Ltd.TATEBAYASHI-SHI Gunma, JapanManufacturer1July 7, 2000000api.fda.gov
Phenox LimitedGalway Galway(County), IrelandManufacturer1October 9, 2019000api.fda.gov
Procedure Products, Inc.Vancouver, WA, United StatesManufacturer1December 10, 1992000api.fda.gov
Rapid-Medical Ltdyokneam Northern, IsraelComplaint file establishment, Manufacturer1September 18, 2026000api.fda.gov
Solo Pace IncBrooklyn Park, MN, United StatesSpecification developer1January 9, 2026000api.fda.gov
Spectranetics Corp.Colorado Springs, CO, United StatesComplaint file establishment, Specification developer1February 26, 2008000api.fda.gov
Stereotaxis, Inc.Saint Louis, MO, United StatesManufacturer1August 24, 2007000api.fda.gov
Sureax Medical, CorporationSan Diego, CA, United StatesComplaint file establishment, Repackager or relabeler, Reprocessor, Specification developer1October 17, 2025000api.fda.gov
Toray Industries, Inc.CHUO-KU Tokyo, JapanComplaint file establishment, Specification developer1December 17, 2004000api.fda.gov
Toray Industries, Inc. Seta PlantOTSU Shiga, JapanManufacturer1December 17, 2004000api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.MEXICALI Baja California, MexicoManufacturer1May 17, 2022000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer1July 18, 2002000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer1July 18, 2002000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer1December 10, 2014000api.fda.gov
Advanced Lifesciences Pvt. Ltd.New Delhi, IndiaExporter to the US, Manufacturer0000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer0000api.fda.gov
Arbor EndovascularSan Jose, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Artiria Medical SAGeneva Geneve, SwitzerlandManufacturer0000api.fda.gov
Asahi Intecc (thailand) Co., Ltd.Amphur Muang Pathumthani Pathum Thani, ThailandContract manufacturer0000api.fda.gov
Asahi Intecc Hanoi Co., Ltd.Hanoi Ha Noi, VietnamContract manufacturer0000api.fda.gov
Abbott MedicalWestford, MA, United StatesSpecification developer0000api.fda.gov
Abbott VascularEl Coyol Alajuela, Costa RicaExporter to the US, Manufacturer0000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
B. Braun Dominican Republic Inc.SANTO DOMINGO Distrito Nacional, Dominican RepublicContract manufacturer0000api.fda.gov
Balt ExtrusionMONTMORENCY Val-d'Oise, FranceContract manufacturer0000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesManufacturer0000api.fda.gov
Biomerics CartagoCartago, Costa RicaContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical TechnologiesSan Pedro de Macoris, Dominican RepublicContract manufacturer0000api.fda.gov
Centerline BiomedicalCleveland, OH, United StatesManufacturer0000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Cardiva Medical, Inc.Guaymas Sonora, MexicoContract manufacturer0000api.fda.gov
Deepintec Scientific Co., LtdBeijing, ChinaManufacturer0000api.fda.gov
Epflex Feinwerktechnik GMBHDETTINGEN/ERMS Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer0000api.fda.gov
Heraeus Medical Components, SRLGuadalupe Cartago, Costa RicaContract manufacturer0000api.fda.gov
Honduras Kitting, S.A.Villanueva Cortes, HondurasContract manufacturer0000api.fda.gov
I-Tek Medical, Inc.White Bear Lake, MN, United StatesContract manufacturer0000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer0000api.fda.gov
Mehow Innovative (huizhou) Ltd.Huizhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
NeedleTech Products, Inc.N Attleboro, MA, United StatesContract manufacturer0000api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Philips Medical Systems Nederland B.V.BEST Noord-Brabant, NetherlandsContract manufacturer0000api.fda.gov
Philips Medical Systems Nederland B.V.Best Noord-Brabant, NetherlandsSpecification developer0000api.fda.gov
Piolax Medical Devices, Inc.Yokohama Kanagawa, JapanContract manufacturer0000api.fda.gov
Piraeus Medical, Inc.Maple Grove, MN, United StatesManufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Shanghai Achieva Medical Suzhou Co., Ltd.Suzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Straub Medical AGWangs Sankt Gallen, SwitzerlandManufacturer0000api.fda.gov
Suzhou Zenith Vascular Scitech LimitedSuzhou Jiangsu, ChinaManufacturer0000api.fda.gov
St. Jude Medical, Atrial Fibrillation Division, Inc.Saint Paul, MN, United StatesManufacturer0000api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.NUEVO LAREDO Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.TECATE Baja California, MexicoContract manufacturer0000api.fda.gov
Terumo Yamaguchi CorporationYamaguchi-shi, JapanContract manufacturer, Contract sterilizer0000api.fda.gov
Theragenics Costa Rica LimitadaEl Coyol, Alajuela, Costa RicaManufacturer0000api.fda.gov
Toyoflex Cebu CorporationLapu-Lapu Cebu(Province), PhilippinesContract manufacturer0000api.fda.gov
Venusa de Mexico S. de R.L de C.VCIUDAD JUAREZ Chihuahua, MexicoContract manufacturer0000api.fda.gov
Yokowo Co., LtdTomioka Gunma, JapanContract manufacturer0000api.fda.gov
Zurich Medical IncPlymouth, MN, United StatesManufacturer0000api.fda.gov

Updated October 16, 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.