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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.

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Product code
KRA
Device class
2
Regulation
870.1210
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States64
Ireland5
Costa Rica5
Mexico4
China4
Japan3
France3
Dominican Republic2
India2
Switzerland1
Singapore1
Israel1
Mauritius1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer11April 25, 2019031api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesSpecification developer10February 16, 2021000api.fda.gov
Micro Therapeutics, Inc. Dba Ev3 NeurovascularIrvine, CA, United StatesManufacturer10February 16, 2021000api.fda.gov
Cerenovus, Inc.Miami, FL, United StatesSpecification developer8April 12, 2022000api.fda.gov
Cordis de Mexico SA de CVCiudad Juarez, Chihuahua Mexico, MexicoExporter to the US, Manufacturer8April 12, 2022000api.fda.gov
Covidien- Santo Domingo, Dominican RepublicContract manufacturer, Manufacturer8December 9, 2009000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer7April 12, 2022000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer, Manufacturer for export7March 30, 2023050api.fda.gov
Becton, Dickinson And CompanyIrvine, CA, United StatesSpecification developer6November 8, 2018000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer6May 15, 2026000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer6May 15, 2026000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer6May 15, 2026010api.fda.gov
Boston Scientific CorporationLa Aurora Heredia, Costa RicaManufacturer, Specification developer5July 28, 2020000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer5May 15, 2026000api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AGHAINA San Cristobal, Dominican RepublicManufacturer5November 8, 2018020api.fda.gov
Stryker NeurovascularFremont, CA, United StatesComplaint file establishment, Specification developer3August 3, 2000000api.fda.gov
Surefire Medical, Inc.Westminster, CO, United StatesComplaint file establishment, Manufacturer3September 21, 2026000api.fda.gov
Ashitaka Factory Of Terumo Corp.FUJINOMIYA Shizuoka, JapanManufacturer2September 26, 2008000api.fda.gov
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer2July 19, 2022000api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.ENSENADA, Baja California, MexicoContract manufacturer, Manufacturer, Repackager or relabeler2September 19, 2007000api.fda.gov
Icu Medical, IncSalt Lake City, UT, United StatesContract manufacturer, Manufacturer, Specification developer2September 19, 2007000api.fda.gov
Instylla, Inc.Bedford, MA, United StatesManufacturer2April 15, 2021000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer2February 6, 1989000api.fda.gov
Ablative Solutions, Inc.Wakefield, MA, United StatesComplaint file establishment, Manufacturer for export, Specification developer1July 5, 2023000api.fda.gov
Agile Devices, Inc.Newton Centre, MA, United StatesManufacturer1January 7, 2022000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer, Repackager or relabeler, Specification developer1March 29, 2007000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesSpecification developer1May 15, 2026010api.fda.gov
Edwards Lifesciences Technology SarlAnasco, PR, United StatesManufacturer1April 8, 1993000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.APODACA Nuevo Leon, MexicoManufacturer1March 23, 1979000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler1September 16, 2011000api.fda.gov
Mercator Medsystems, Inc.San Leandro, CA, United StatesManufacturer1August 2, 2021000api.fda.gov
Micro Medical Solutions IncWoburn, MA, United StatesManufacturer1March 9, 2016000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer1September 18, 2009000api.fda.gov
Merit Medical Singapore Pte. Ltd.SINGAPORE Central Singapore, SingaporeManufacturer1October 2, 1979000api.fda.gov
Suzhou Hengrui Hongyuan Medical Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1April 11, 2022000api.fda.gov
Suzhou Zenith Vascular Scitech LimitedSuzhou Jiangsu, ChinaManufacturer1July 30, 2025000api.fda.gov
Stryker NeurovascularCork Munster, IrelandManufacturer1August 3, 2000000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1December 7, 1987000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1November 22, 1978000api.fda.gov
Vascupatent Medical (shenzhen) Co., LtdShenzhen Guangdong, ChinaManufacturer1November 7, 2022000api.fda.gov
VVT MED LtdKfar Saba Central, IsraelManufacturer1June 20, 2023000api.fda.gov
Wallaby MedicalLaguna Hills, CA, United StatesSpecification developer1April 25, 2023000api.fda.gov
Zien Medical Technologies LLCSalt Lake City, UT, United StatesManufacturer1November 29, 2023000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer, Specification developer1August 1, 2012000api.fda.gov
Alembic LLCMountain View, CA, United StatesContract manufacturer0000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer0040api.fda.gov
Armor Plast LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
AUSA Medical Device Pvt LtdBangalore Karnataka, IndiaContract manufacturer0000api.fda.gov
Akita Sumitomo Bakelite Co., Ltd.Akita, JapanContract manufacturer0000api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer0000api.fda.gov
Balt ExtrusionMONTMORENCY Val-d'Oise, FranceContract manufacturer0000api.fda.gov
Boulder Biomed LLCBoulder, CO, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer0010api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer0000api.fda.gov
Boston Scientific CorporationDorado, PR, United StatesManufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer0000api.fda.gov
Creganna Medical S. R. LSan Rafael Heredia, Costa RicaContract manufacturer0000api.fda.gov
Edwards Lifesciences LLCIrvine, CA, United StatesSpecification developer0020api.fda.gov
Endovascular Engineering, Inc.Menlo Park, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Expanse Medical Inc.Pleasanton, CA, United StatesManufacturer0000api.fda.gov
Flowphysix, Inc.West Lake Hills, TX, United StatesSpecification developer0000api.fda.gov
Goodwill Commercial ServicesIndianapolis, IN, United StatesContract manufacturer0000api.fda.gov
HexacathRueil Malmaison Ile-de-France, FranceManufacturer0000api.fda.gov
Imperative Care Inc.Campbell, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Inquis Medical, Inc.Menlo Park, CA, United StatesManufacturer0000api.fda.gov
Intervene IncRedwood City, CA, United StatesManufacturer0000api.fda.gov
Inari Medical, Costa Rica S.R.L.Grecia Alajuela, Costa RicaManufacturer0000api.fda.gov
Inari Medical, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Innova Vascular, Inc.Irvine, CA, United StatesManufacturer0000api.fda.gov
Kaneka Americas Holding IncNewark, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Lemaitre Vascular, Inc.Burlington, MA, United StatesManufacturer0000api.fda.gov
Liquet Medical Inc.Glen Allen, VA, United StatesSpecification developer0000api.fda.gov
LeMaitre Vascular Inc.Billerica, MA, United StatesManufacturer0000api.fda.gov
M4D LLCLake Forest, CA, United StatesContract manufacturer0000api.fda.gov
Medtronic VascularDanvers, MA, United StatesManufacturer0000api.fda.gov
Merit Medical Ireland, LtdGalway Galway(County), IrelandManufacturer0000api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
MicroVention Costa Rica S.R.L.. Alajuela, Costa RicaContract manufacturer0000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer0000api.fda.gov
Natec Medical LtdMoka, MauritiusContract manufacturer0000api.fda.gov
Nexstep MedicalDijon Cote-d'Or, FranceComplaint file establishment, Specification developer0000api.fda.gov
NexternMaple Grove, MN, United StatesContract manufacturer0000api.fda.gov
PDV MedTechMorgan Hill, CA, United StatesContract manufacturer0000api.fda.gov
Roechling Medical Lancaster, LLCDenver, PA, United StatesContract manufacturer0000api.fda.gov
Summa Therapeutics, LLCAllston, MA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Surgical Technologies, Inc.St. Paul, MN, United StatesContract manufacturer0000api.fda.gov
Surmodics, Inc.Eden Prairie, MN, United StatesComplaint file establishment, Contract manufacturer, Repackager or relabeler, Specification developer0000api.fda.gov
Shanghai Wallaby Medical Technologies CO., Inc.Shanghai, ChinaContract manufacturer0000api.fda.gov
Terumo Clinical Supply Co., Ltd.Kakamigahara Gifu, JapanManufacturer0000api.fda.gov
Thrombolex, Inc.New Britain, PA, United StatesSpecification developer0000api.fda.gov
Tiercel SurgicalNew Britain, PA, United StatesContract manufacturer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesManufacturer0000api.fda.gov
VesalioSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Vetex Medical LimitedBallinasloe Galway(County), IrelandSpecification developer0000api.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.