Skip to the page

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

CountryMakers
United States21
Mexico6
France2
Germany2
China2
Switzerland1
Costa Rica1
South Korea1
Singapore1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer23September 5, 2025040api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesManufacturer19May 22, 2020010api.fda.gov
AngioDynamics, Inc.Marlborough, MA, United StatesSpecification developer19May 22, 2020000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer15March 1, 2010000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer9May 21, 2015010api.fda.gov
Icu Medical, Inc.San Clemente, CA, United StatesComplaint file establishment, Specification developer7March 1, 2010000api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Manufacturer, Specification developer7March 15, 2016080api.fda.gov
PFM Medical, IncCarlsbad, CA, United StatesComplaint file establishment, Specification developer5July 16, 2013000api.fda.gov
pfm medical cpp SALA CHAUX-DE-FONDS Neuchatel, SwitzerlandComplaint file establishment, Manufacturer5July 16, 2013000api.fda.gov
Norfolk Medical Products, Inc.Skokie, IL, United StatesManufacturer3October 27, 2011000api.fda.gov
Arrow Internacional de Chihuahua S.A. de C.V.Chihuahua, MexicoExporter to the US, Manufacturer, Repackager or relabeler1October 27, 2000000api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer1October 27, 2000010api.fda.gov
B. Braun MedicalCHASSENEUIL-DU-POITOU Vienne, FranceManufacturer1April 2, 2013010api.fda.gov
CovidienNorth Haven, CT, United StatesManufacturer1August 10, 1995000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer1July 14, 1994000api.fda.gov
PHS Medical GMBHFuldabrueck Hesse, GermanyContract manufacturer, Manufacturer1May 22, 2009000api.fda.gov
Perouse MedicalFRANCE Oise, FranceSpecification developer1December 11, 2013000api.fda.gov
Portal Access IncMiami Beach, FL, United StatesComplaint file establishment, Specification developer1June 17, 2026000api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler1October 27, 2000000api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer1December 11, 2013000api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer1December 11, 2013000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Cook IncorporatedEllettsville, IN, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Cy Medical Co., Ltd.Eumseong-gun Chungbuk, South KoreaContract manufacturer0000api.fda.gov
EPIC MedTec OEM Catheter & Wire LLCPlymouth, MN, United StatesContract manufacturer0000api.fda.gov
Forefront Medical Technology (jiangsu) Co.,ltdChangzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
Forefront Medical Technology (pte) Ltd.SINGAPORE South West, SingaporeContract manufacturer0000api.fda.gov
Grupo American Industries, S.A. De C.VCiudad Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Integra Biotechnical, SA de CVTijuana Baja California, MexicoContract manufacturer0000api.fda.gov
IntriCon Corporation VHVadnais Heights, MN, United StatesContract manufacturer0000api.fda.gov
Martech Medical Products S. De RL. De CV.MEXICALI Baja California, MexicoContract manufacturer0000api.fda.gov
Primrose Medical, Inc.East Walpole, MA, United StatesManufacturer0000api.fda.gov
Primo Medical Group, INCStoughton, MA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Sterilization Services Of Georgia, Inc.Atlanta, GA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Turnxon Precision Co., LtdDongguan Guangdong, ChinaContract manufacturer0000api.fda.gov
pfm medical mepro gmbhNonnweiler-Otzenhausen Saarland, GermanyContract manufacturer0000api.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.