Data / Medical devices / Port & Catheter, Implanted, Subcutaneous, Intravascular
Port & Catheter, Implanted, Subcutaneous, Intravascular (LJT): 37 FDA-registered makers in 9 countries
37 establishments in 9 countries are registered with the FDA to make Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT, Class 2, 21 CFR 880.5965). 21 of them have a 510(k) clearance or PMA approval on file and 6 have a recall event. The FDA has issued 288 510(k) clearances under this code, the latest on June 17, 2026, and lists 47 recall events (2 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.
- Product code
- LJT
- Device class
- 2
- Regulation
- 880.5965
- Medical specialty
- General Hospital
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 21 |
| Mexico | 6 |
| France | 2 |
| Germany | 2 |
| China | 2 |
| Switzerland | 1 |
| Costa Rica | 1 |
| South Korea | 1 |
| Singapore | 1 |
Makers of Port & Catheter, Implanted, Subcutaneous, Intravascular
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 |
|---|---|---|---|---|---|---|---|---|
| Bard Access Systems, Inc. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 23 | September 5, 2025 | 0 | 4 | 0 | api.fda.gov |
| Angiodynamics, Inc. | Queensbury, NY, United States | Manufacturer | 19 | May 22, 2020 | 0 | 1 | 0 | api.fda.gov |
| AngioDynamics, Inc. | Marlborough, MA, United States | Specification developer | 19 | May 22, 2020 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 15 | March 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 9 | May 21, 2015 | 0 | 1 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 7 | March 1, 2010 | 0 | 0 | 0 | api.fda.gov |
| Medical Components Inc | Harleysville, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 7 | March 15, 2016 | 0 | 8 | 0 | api.fda.gov |
| PFM Medical, Inc | Carlsbad, CA, United States | Complaint file establishment, Specification developer | 5 | July 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| pfm medical cpp SA | LA CHAUX-DE-FONDS Neuchatel, Switzerland | Complaint file establishment, Manufacturer | 5 | July 16, 2013 | 0 | 0 | 0 | api.fda.gov |
| Norfolk Medical Products, Inc. | Skokie, IL, United States | Manufacturer | 3 | October 27, 2011 | 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 | October 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Arrow International, LLC (subsidiary of Teleflex Incorporated) | Wyomissing, PA, United States | Specification developer | 1 | October 27, 2000 | 0 | 1 | 0 | api.fda.gov |
| B. Braun Medical | CHASSENEUIL-DU-POITOU Vienne, France | Manufacturer | 1 | April 2, 2013 | 0 | 1 | 0 | api.fda.gov |
| Covidien | North Haven, CT, United States | Manufacturer | 1 | August 10, 1995 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Neurosurgery | Fort Worth, TX, United States | Specification developer | 1 | July 14, 1994 | 0 | 0 | 0 | api.fda.gov |
| PHS Medical GMBH | Fuldabrueck Hesse, Germany | Contract manufacturer, Manufacturer | 1 | May 22, 2009 | 0 | 0 | 0 | api.fda.gov |
| Perouse Medical | FRANCE Oise, France | Specification developer | 1 | December 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| Portal Access Inc | Miami Beach, FL, United States | Complaint file establishment, Specification developer | 1 | June 17, 2026 | 0 | 0 | 0 | api.fda.gov |
| Teleflex LLC (NADC) | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler | 1 | October 27, 2000 | 0 | 0 | 0 | api.fda.gov |
| Vygon Usa | Lansdale, PA, United States | Specification developer | 1 | December 11, 2013 | 0 | 0 | 0 | api.fda.gov |
| Vygon MFG | Dover, NH, United States | Manufacturer | 1 | December 11, 2013 | 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 | |
| Biomerics Alajuela | Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cook Incorporated | Ellettsville, IN, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cy Medical Co., Ltd. | Eumseong-gun Chungbuk, South Korea | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EPIC MedTec OEM Catheter & Wire LLC | Plymouth, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront Medical Technology (jiangsu) Co.,ltd | Changzhou Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Forefront Medical Technology (pte) Ltd. | SINGAPORE South West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Grupo American Industries, S.A. De C.V | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integra Biotechnical, SA de CV | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation VH | Vadnais Heights, MN, 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 | |
| Primrose Medical, Inc. | East Walpole, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, INC | Stoughton, MA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterilization Services Of Georgia, Inc. | Atlanta, GA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnxon Precision Co., Ltd | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| pfm medical mepro gmbh | Nonnweiler-Otzenhausen Saarland, Germany | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated June 17, 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.