Data / Medical devices / Catheter, Hemodialysis, Triple Lumen, Non-Implanted / United States
FDA-registered makers of Catheter, Hemodialysis, Triple Lumen, Non-Implanted in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Catheter, Hemodialysis, Triple Lumen, Non-Implanted (product code NIE). 6 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 3, 2026.
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- Device
- Catheter, Hemodialysis, Triple Lumen, Non-Implanted
- Product code
- NIE
- Country
- United States
Makers of Catheter, Hemodialysis, Triple Lumen, Non-Implanted in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | November 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Specification developer | 2 | June 1, 2015 | 0 | 1 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 2 | December 22, 2010 | 0 | 3 | 2 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 2 | December 22, 2010 | 0 | 1 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | July 24, 2015 | 0 | 1 | 0 | api.fda.gov |
| Health Line International Corporation | Salt Lake City, UT, United States | Manufacturer | 1 | January 13, 2023 | 0 | 0 | 0 | api.fda.gov |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.