Data / Medical devices / Catheter, Subclavian
Catheter, Subclavian (LFJ): 14 FDA-registered makers in 4 countries
14 establishments in 4 countries are registered with the FDA to make Catheter, Subclavian (product code LFJ, Class 2, 21 CFR 876.5540). 7 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 65 510(k) clearances under this code, the latest on August 19, 1994, and lists 4 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- LFJ
- Device class
- 2
- Regulation
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 8 |
| Mexico | 3 |
| Czechia | 2 |
| China | 1 |
Makers of Catheter, Subclavian
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 |
|---|---|---|---|---|---|---|---|---|
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | February 2, 1993 | 0 | 3 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 3 | February 17, 1988 | 0 | 0 | 0 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 3 | February 17, 1988 | 0 | 0 | 0 | api.fda.gov |
| Arrow Internacional de Chihuahua S.A. de C.V. | Chihuahua, Mexico | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | January 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| Arrow International C.R. a.s. | ZDAR NAD SAZAVOU Vysocina, Czechia | Exporter to the US, Manufacturer, Repackager or relabeler | 1 | January 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | Manufacturer | 1 | January 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | January 3, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bard Reynosa S.A. De C.V. | REYNOSA Tamaulipas, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products | Harleysville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Martech Medical Products S. De RL. De CV. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medron, LLC | Salt Lake City, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Point Medical Corp. | Crown Point, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical - Mansfield, Bridgemedica | Mansfield, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnxon Precision Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 19, 1994. 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.