Data / Medical devices / Catheter, Intravascular, Diagnostic / United States
FDA-registered makers of Catheter, Intravascular, Diagnostic in the United States: 61 establishments
61 establishments in the United States are registered with the FDA to make Catheter, Intravascular, Diagnostic (product code DQO). 45 have a 510(k) clearance or PMA approval on file and 14 have a recall event. FDA data exported November 2, 2026.
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- Device
- Catheter, Intravascular, Diagnostic
- Product code
- DQO
- Country
- United States
Makers of Catheter, Intravascular, Diagnostic in the United States
| 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 |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 9 | November 21, 2023 | 0 | 5 | 2 | 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 |
| 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 | Coventry, RI, United States | 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, 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 |
| 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 |
| 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 International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 2 | November 6, 1989 | 0 | 1 | 0 | api.fda.gov |
| Curatia Medical Co. | Sunnyvale, CA, United States | Specification developer | 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 |
| Procedure Products, Inc. | Vancouver, WA, United States | Manufacturer | 2 | November 27, 1991 | 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 |
| 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 |
| 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 |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Repackager or relabeler, Specification developer | 1 | August 2, 2012 | 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 |
| 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 |
| 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 | |
| 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 | |
| Harmac Medical Products, Inc. | Buffalo, NY, United States | 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 | |
| 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 | |
| Merit Medical Systems, Inc. | Houston, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Prytime Medical Devices, Inc. | Lakewood, CO, United States | Specification developer | 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 | |
| Sterilization Services Of Virginia | Richmond, VA, United States | Contract manufacturer, Contract sterilizer | 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 | |
| Verge Medical Inc. | Campbell, CA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.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.