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Data / Medical devices / Catheter, Continuous Flush / United States

FDA-registered makers of Catheter, Continuous Flush in the United States: 64 establishments

64 establishments in the United States are registered with the FDA to make Catheter, Continuous Flush (product code KRA). 27 have a 510(k) clearance or PMA approval on file and 6 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Continuous Flush
Product code
KRA
Country
United States

Makers of Catheter, Continuous Flush in the United States

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
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
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
Balt Usa, LLCIrvine, CA, United StatesComplaint file establishment, Manufacturer2July 19, 2022000api.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
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
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
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
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer0000api.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 CorporationDorado, PR, United StatesManufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer0000api.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
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, 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
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer0000api.fda.gov
Merit Medical Systems, Inc.Houston, TX, United StatesContract manufacturer0000api.fda.gov
MicroVention, Inc.Aliso Viejo, CA, United StatesManufacturer0000api.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
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

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.