Data / Medical devices / Catheter, Continuous Flush
Catheter, Continuous Flush (KRA): 96 FDA-registered makers in 13 countries
96 establishments in 13 countries are registered with the FDA to make Catheter, Continuous Flush (product code KRA, Class 2, 21 CFR 870.1210). 44 of them have a 510(k) clearance or PMA approval on file and 8 have a recall event. The FDA has issued 177 510(k) clearances under this code, the latest on September 21, 2026, and lists 50 recall events (3 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
- KRA
- Device class
- 2
- Regulation
- 870.1210
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 64 |
| Ireland | 5 |
| Costa Rica | 5 |
| Mexico | 4 |
| China | 4 |
| Japan | 3 |
| France | 3 |
| Dominican Republic | 2 |
| India | 2 |
| Switzerland | 1 |
| Singapore | 1 |
| Israel | 1 |
| Mauritius | 1 |
Makers of Catheter, Continuous Flush
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 | April 25, 2019 | 0 | 3 | 1 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Specification developer | 10 | February 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Micro Therapeutics, Inc. Dba Ev3 Neurovascular | Irvine, CA, United States | Manufacturer | 10 | February 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Cerenovus, Inc. | Miami, FL, United States | Specification developer | 8 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cordis de Mexico SA de CV | Ciudad Juarez, Chihuahua Mexico, Mexico | Exporter to the US, Manufacturer | 8 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Covidien | - Santo Domingo, Dominican Republic | Contract manufacturer, Manufacturer | 8 | December 9, 2009 | 0 | 0 | 0 | api.fda.gov |
| Medos International Sarl | Le Locle Neuchatel, Switzerland | Specification developer | 7 | April 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Systems, Inc. | South Jordan, UT, United States | Manufacturer, Manufacturer for export | 7 | March 30, 2023 | 0 | 5 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 6 | November 8, 2018 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Manufacturer | 6 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 6 | May 15, 2026 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | CORK Munster, Ireland | Manufacturer | 6 | May 15, 2026 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Corporation | La Aurora Heredia, Costa Rica | Manufacturer, Specification developer | 5 | July 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer | 5 | May 15, 2026 | 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 | 5 | November 8, 2018 | 0 | 2 | 0 | api.fda.gov |
| Stryker Neurovascular | Fremont, CA, United States | Complaint file establishment, Specification developer | 3 | August 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Surefire Medical, Inc. | Westminster, CO, United States | Complaint file establishment, Manufacturer | 3 | September 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Ashitaka Factory Of Terumo Corp. | FUJINOMIYA Shizuoka, Japan | Manufacturer | 2 | September 26, 2008 | 0 | 0 | 0 | api.fda.gov |
| Balt Usa, LLC | Irvine, CA, United States | Complaint file establishment, Manufacturer | 2 | July 19, 2022 | 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 | 2 | September 19, 2007 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc | Salt Lake City, UT, United States | Contract manufacturer, Manufacturer, Specification developer | 2 | September 19, 2007 | 0 | 0 | 0 | api.fda.gov |
| Instylla, Inc. | Bedford, MA, United States | Manufacturer | 2 | April 15, 2021 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 2 | February 6, 1989 | 0 | 0 | 0 | api.fda.gov |
| Ablative Solutions, Inc. | Wakefield, MA, United States | Complaint file establishment, Manufacturer for export, Specification developer | 1 | July 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Agile Devices, Inc. | Newton Centre, MA, United States | Manufacturer | 1 | January 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| Argon Medical Devices Inc. | Athens, TX, United States | Manufacturer, Repackager or relabeler, Specification developer | 1 | March 29, 2007 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Specification developer | 1 | May 15, 2026 | 0 | 1 | 0 | api.fda.gov |
| Edwards Lifesciences Technology Sarl | Anasco, PR, United States | Manufacturer | 1 | April 8, 1993 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 1 | March 23, 1979 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 1 | September 16, 2011 | 0 | 0 | 0 | api.fda.gov |
| Mercator Medsystems, Inc. | San Leandro, CA, United States | Manufacturer | 1 | August 2, 2021 | 0 | 0 | 0 | api.fda.gov |
| Micro Medical Solutions Inc | Woburn, MA, United States | Manufacturer | 1 | March 9, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 1 | September 18, 2009 | 0 | 0 | 0 | api.fda.gov |
| Merit Medical Singapore Pte. Ltd. | SINGAPORE Central Singapore, Singapore | Manufacturer | 1 | October 2, 1979 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Hengrui Hongyuan Medical Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | April 11, 2022 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Zenith Vascular Scitech Limited | Suzhou Jiangsu, China | Manufacturer | 1 | July 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Stryker Neurovascular | Cork Munster, Ireland | Manufacturer | 1 | August 3, 2000 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | December 7, 1987 | 0 | 0 | 0 | api.fda.gov |
| Utah Medical Products, Inc. | Midvale, UT, United States | Manufacturer | 1 | November 22, 1978 | 0 | 0 | 0 | api.fda.gov |
| Vascupatent Medical (shenzhen) Co., Ltd | Shenzhen Guangdong, China | Manufacturer | 1 | November 7, 2022 | 0 | 0 | 0 | api.fda.gov |
| VVT MED Ltd | Kfar Saba Central, Israel | Manufacturer | 1 | June 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wallaby Medical | Laguna Hills, CA, United States | Specification developer | 1 | April 25, 2023 | 0 | 0 | 0 | api.fda.gov |
| Zien Medical Technologies LLC | Salt Lake City, UT, United States | Manufacturer | 1 | November 29, 2023 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer, Specification developer | 1 | August 1, 2012 | 0 | 0 | 0 | api.fda.gov |
| Alembic LLC | Mountain View, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 0 | 0 | 4 | 0 | api.fda.gov | |
| Armor Plast Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AUSA Medical Device Pvt Ltd | Bangalore Karnataka, India | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Akita Sumitomo Bakelite Co., Ltd. | Akita, Japan | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Balt Extrusion | MONTMORENCY Val-d'Oise, France | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boulder Biomed LLC | Boulder, CO, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Boston Scientific Corporation | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Dorado, PR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 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 | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Specification developer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Endovascular Engineering, Inc. | Menlo Park, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Expanse Medical Inc. | Pleasanton, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flowphysix, Inc. | West Lake Hills, TX, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Goodwill Commercial Services | Indianapolis, IN, 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 | |
| Imperative Care Inc. | Campbell, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inquis Medical, Inc. | Menlo Park, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intervene Inc | Redwood City, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inari Medical, Costa Rica S.R.L. | Grecia Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inari Medical, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innova Vascular, Inc. | Irvine, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Kaneka Americas Holding Inc | Newark, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | 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 | |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| M4D LLC | Lake Forest, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtronic Vascular | Danvers, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Merit Medical Ireland, Ltd | Galway Galway(County), Ireland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 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 | |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Natec Medical Ltd | Moka, Mauritius | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nexstep Medical | Dijon Cote-d'Or, France | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nextern | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| PDV MedTech | Morgan Hill, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roechling Medical Lancaster, LLC | Denver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summa Therapeutics, LLC | Allston, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Technologies, Inc. | St. Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surmodics, Inc. | Eden Prairie, MN, United States | Complaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Wallaby Medical Technologies CO., Inc. | Shanghai, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Terumo Clinical Supply Co., Ltd. | Kakamigahara Gifu, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Thrombolex, Inc. | New Britain, PA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tiercel Surgical | New Britain, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vascular Solutions LLC | Maple Grove, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vesalio | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vetex Medical Limited | Ballinasloe Galway(County), Ireland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 21, 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.