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Data / Medical devices / Catheter, Hemodialysis, Triple Lumen, Non-Implanted

Catheter, Hemodialysis, Triple Lumen, Non-Implanted (NIE): 13 FDA-registered makers in 4 countries

13 establishments in 4 countries are registered with the FDA to make Catheter, Hemodialysis, Triple Lumen, Non-Implanted (product code NIE, Class 2, 21 CFR 876.5540). 9 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 12 510(k) clearances under this code, the latest on November 16, 2023, and lists 8 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.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
NIE
Device class
2
Regulation
876.5540
Medical specialty
Gastroenterology, Urology
Life sustaining or supporting
Yes

Makers by country

CountryMakers
United States7
Mexico4
Czechia1
Costa Rica1

Makers of Catheter, Hemodialysis, Triple Lumen, Non-Implanted

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
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer5November 16, 2023000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer, Repackager or relabeler2June 1, 2015000api.fda.gov
Bard Access Systems, Inc.Salt Lake City, UT, United StatesSpecification developer2June 1, 2015010api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer2December 22, 2010032api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer2December 22, 2010010api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler1July 24, 2015000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaManufacturer1July 24, 2015000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1July 24, 2015010api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer1January 13, 2023000api.fda.gov
Cardinal Health Costa Rica, S.A.-- Alajuela, Costa RicaContract manufacturer0000api.fda.gov
CovidienTIJUANA, B.C. Mexico, MexicoManufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov

Updated November 16, 2023. 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.