Data / Medical devices / Catheter, Intravascular, Diagnostic
Catheter, Intravascular, Diagnostic (DQO): 124 FDA-registered makers in 19 countries
124 establishments in 19 countries are registered with the FDA to make Catheter, Intravascular, Diagnostic (product code DQO, Class 2, 21 CFR 870.1200). 76 of them have a 510(k) clearance or PMA approval on file and 14 have a recall event. The FDA has issued 501 510(k) clearances under this code, the latest on June 26, 2026, and lists 79 recall events (15 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
- DQO
- Device class
- 2
- Regulation
- 870.1200
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 61 |
| Mexico | 18 |
| China | 8 |
| Ireland | 5 |
| France | 5 |
| Costa Rica | 4 |
| Japan | 3 |
| Singapore | 3 |
| Dominican Republic | 3 |
| Netherlands | 2 |
| India | 2 |
| Canada | 2 |
| Israel | 2 |
| Switzerland | 1 |
| Czechia | 1 |
| Belgium | 1 |
| Malaysia | 1 |
| Germany | 1 |
| South Korea | 1 |
Makers of Catheter, Intravascular, Diagnostic
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 | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 11 | March 22, 2019 | 0 | 7 | 4 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 10 | July 17, 2025 | 0 | 0 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 9 | November 21, 2023 | 0 | 5 | 2 | api.fda.gov |
| Cardinal Health Mexico 244 S de RL de CV | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer, Manufacturer | 8 | November 21, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 7 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 7 | November 20, 2009 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Specification developer | 7 | May 22, 2024 | 0 | 14 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler | 6 | June 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Specification developer | 5 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Bioptimal International Pte. Ltd. | SINGAPORE South East, Singapore | Manufacturer | 5 | May 28, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 5 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 5 | October 29, 2015 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Industries, Inc. | Powell, TN, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | July 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| ICU MEDICAL DE MEXICO, S. de R.L. de C.V. | ENSENADA, Baja California, Mexico | Contract manufacturer, Manufacturer, Repackager or relabeler | 5 | December 22, 2005 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Specification developer | 4 | December 13, 1994 | 0 | 0 | 0 | api.fda.gov |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 4 | January 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer | 4 | January 6, 2017 | 0 | 0 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 3 | July 18, 2018 | 0 | 3 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 3 | July 18, 2018 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 3 | March 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 3 | November 26, 2002 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 3 | August 8, 1995 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Canton, IL, United States | Manufacturer | 3 | October 5, 2018 | 0 | 0 | 0 | api.fda.gov |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Manufacturer | 3 | August 8, 1995 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 3 | March 8, 2002 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Westford, MA, United States | Manufacturer | 2 | April 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 2 | November 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| Arrow International C.R. a.s. | ZDAR NAD SAZAVOU Vysocina, Czechia | Exporter to the US, Manufacturer, Repackager or relabeler | 2 | November 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 2 | November 6, 1989 | 0 | 1 | 0 | api.fda.gov |
| CD Leycom | Hengelo Overijssel, Netherlands | Exporter to the US, Specification developer | 2 | December 9, 2003 | 0 | 0 | 0 | api.fda.gov |
| Curatia Medical Co. | Sunnyvale, CA, United States | Specification developer | 2 | March 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Curatia Medical Limited | Suzhou Jiangsu, China | Manufacturer | 2 | March 4, 2013 | 0 | 0 | 0 | api.fda.gov |
| Enablecv, LLC | Midvale, UT, United States | Specification developer | 2 | February 11, 2011 | 0 | 0 | 0 | api.fda.gov |
| Gentuity, LLC | Sudbury, MA, United States | Complaint file establishment, Manufacturer | 2 | January 31, 2025 | 0 | 1 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 2 | December 22, 2005 | 0 | 2 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer, Specification developer | 2 | August 19, 2016 | 0 | 3 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 2 | April 2, 1996 | 0 | 1 | 0 | api.fda.gov |
| Phenox Limited | Galway Galway(County), Ireland | Manufacturer | 2 | November 12, 2024 | 0 | 0 | 0 | api.fda.gov |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 2 | November 27, 1991 | 0 | 0 | 0 | api.fda.gov |
| Sipv | Ecouen Ile-de-France, France | Manufacturer | 2 | November 27, 1981 | 0 | 0 | 0 | api.fda.gov |
| Spectrum Vascular | Warren, NJ, United States | Specification developer | 2 | December 19, 2018 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 2 | November 22, 2019 | 0 | 2 | 0 | api.fda.gov |
| Stryker Neurovascular | Salt Lake City, UT, United States | Manufacturer | 2 | November 22, 2019 | 0 | 1 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | June 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer | 2 | June 17, 2022 | 0 | 7 | 4 | api.fda.gov |
| Vygon S A | ECOUEN 95440 Val-d'Oise, France | Manufacturer | 2 | November 27, 1981 | 0 | 0 | 0 | api.fda.gov |
| Advanced Lifesciences Pvt. Ltd. | New Delhi, India | Exporter to the US, Manufacturer | 1 | October 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Advanced Vascular Dynamics | Tigard, OR, United States | Manufacturer, Specification developer | 1 | July 19, 1983 | 0 | 0 | 0 | api.fda.gov |
| Allwell Medical Corporation | Raleigh, NC, United States | Repackager or relabeler, Specification developer | 1 | October 10, 1978 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | Chelmsford, MA, United States | Contract manufacturer, Manufacturer | 1 | November 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| B. Braun Medical Inc. | Bethlehem, PA, United States | Specification developer | 1 | November 2, 1976 | 0 | 0 | 0 | api.fda.gov |
| Biocardia, Inc. | Sunnyvale, CA, United States | Manufacturer | 1 | January 24, 2002 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 1 | September 14, 2012 | 0 | 11 | 3 | api.fda.gov |
| Cook, Inc. | Bloomington, IN, United States | Manufacturer | 1 | November 15, 2017 | 0 | 0 | 0 | api.fda.gov |
| Conavi Medical Inc | Toronto Ontario, Canada | Manufacturer | 1 | March 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Deroyal Intercontinental, S.R.L. | Santiago, Dominican Republic | Contract manufacturer, Repackager or relabeler | 1 | November 25, 1991 | 0 | 0 | 0 | api.fda.gov |
| Dimequip | Frameries Hainaut, Belgium | Manufacturer | 1 | November 27, 1981 | 0 | 0 | 0 | api.fda.gov |
| Embolx Inc. | Sunnyvale, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | February 23, 2024 | 0 | 0 | 0 | api.fda.gov |
| Hosmed Inc. | Doral, FL, United States | Manufacturer, Repackager or relabeler | 1 | July 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Specification developer | 1 | April 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 16, 1980 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Singapore Pte. Ltd. | SINGAPORE Central Singapore, Singapore | Manufacturer | 1 | March 16, 1983 | 0 | 0 | 0 | api.fda.gov |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Repackager or relabeler, Specification developer | 1 | August 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Numed Canada, Inc. | CORNWALL Ontario, Canada | Manufacturer | 1 | April 2, 1996 | 0 | 0 | 0 | api.fda.gov |
| Oscor Inc. | Palm Harbor, FL, United States | Complaint file establishment, Manufacturer | 1 | January 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| Productos Medline S.A. De C.V. | NUEVO LAREDO Tamaulipas, Mexico | Manufacturer | 1 | October 18, 1984 | 0 | 0 | 0 | api.fda.gov |
| Rci Hudson De Mexico S. De RL. De CV. | Nuevo Laredo Tamaulipas, Mexico | Manufacturer | 1 | October 18, 1984 | 0 | 0 | 0 | api.fda.gov |
| Shenzhen Antmed Co. Ltd | Dongguan Guangdong, China | Manufacturer | 1 | February 26, 2014 | 0 | 0 | 0 | api.fda.gov |
| Sipa | Avesnes Sur Helpe Hauts-de-France, France | Manufacturer | 1 | November 27, 1981 | 0 | 0 | 0 | api.fda.gov |
| Sunny Medical Device (shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 1 | March 20, 2015 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 1 | August 18, 2014 | 0 | 0 | 0 | api.fda.gov |
| Surefire Medical, Inc. | Westminster, CO, United States | Complaint file establishment, Manufacturer | 1 | April 3, 2018 | 0 | 0 | 0 | api.fda.gov |
| Terumo Clinical Supply Co., Ltd. | Kakamigahara Gifu, Japan | Manufacturer | 1 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Togo Medikit Co., Ltd. | HYUGA CITY Miyazaki, Japan | Complaint file establishment, Manufacturer | 1 | July 11, 2012 | 0 | 0 | 0 | api.fda.gov |
| Tri-State De Mexico, S. De R.L. De C.V. | MEXICALI Baja California, Mexico | Manufacturer | 1 | October 18, 1984 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical de Tecate, S. de R.L de C.V. | TECATE Baja California, Mexico | Manufacturer | 1 | June 17, 2022 | 0 | 0 | 0 | api.fda.gov |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Antmed Malaysia Sdn Bhd | Port Dickson Negeri Sembilan, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrotek Medical Ltd | Co. Sligo Connaught, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B. Braun Us Device Manufacturing LLC | Allentown, PA, United States | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| BIOMERICS Advanced Catheter | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bioxin Medical Co., Ltd | Weihai Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG | HAINA San Cristobal, Dominican Republic | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Conod Medical Shuyang Co., Ltd. | Shuyang Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CPE1, LLC DBA Greatbatch Medical | Southwest Ranches, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirtec Medical | Santa Clara, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creganna Medical S. R. L | San Rafael Heredia, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elcam Medical A.C.A.L. | D.N. MEROM HAGALIL Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elcam Medical Acal | DALTON INDUSTRIAL PARK, P.O BOX 9 Northern, Israel | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerald Medical Services Pte. Ltd | Singapore North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM Ireland Limited | ANNACOTTY Limerick(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems (china) Co., Ltd. | WUXI Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hexacath | Rueil Malmaison Ile-de-France, France | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Liquet Medical Inc. | Glen Allen, VA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manufacturas Y Servicios Internacionales, S. De R.L. | Cd Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microtek Dominicana, S.A.S. | La Romana, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MedFact Engineering GmbH | Loerrach Baden-Wurttemberg, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Maquiladora Mexico, S. DE R.L. DE C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroVention Costa Rica S.R.L. | . Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osi Systems Pvt Ltd(optoelectronics Division) | HYDERABAD Telangana, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parallel Design SAS | Valbonne, France | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prytime Medical Devices, Inc. | Lakewood, CO, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Parker Industrial S de RL de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prytime Medical Devices, Inc. | Boerne, TX, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Respicardia, Inc. | Minnetonka, MN, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RM Healthcare Products SA de CV | JUAREZ Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SEI Medical S.A. de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Vivolight Medical Device&technology Co., Ltd. | shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilization Services Of Virginia | Richmond, VA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Siemens Healthineers Ltd. | Pohang-si Gyeongbuk, South Korea | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Teleflex Medical de Mexico, S. de R.L. de C.V. | NUEVO LAREDO Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Unitron Group BV | IJzendijke Zeeland, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Verge Medical Inc. | Campbell, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 26, 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.