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Data / Medical devices / Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days / United States

FDA-registered makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days in the United States: 38 establishments

38 establishments in the United States are registered with the FDA to make Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days (product code LJS). 22 have a 510(k) clearance or PMA approval on file and 12 have a recall event. FDA data exported November 2, 2026.

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Device
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Product code
LJS
Country
United States

Makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Bard Access Systems, Inc.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer46August 24, 20220121api.fda.gov
Medical Components IncHarleysville, PA, United StatesComplaint file establishment, Contract manufacturer, Manufacturer, Specification developer27October 9, 2026040api.fda.gov
Arrow International, LLC (subsidiary of Teleflex Incorporated)Wyomissing, PA, United StatesSpecification developer17August 22, 20220240api.fda.gov
Teleflex LLC (NADC)Olive Branch, MS, United StatesManufacturer, Repackager or relabeler15December 22, 2016000api.fda.gov
Spectrum VascularWarren, NJ, United StatesManufacturer, Specification developer9December 16, 2025000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer7October 7, 2016010api.fda.gov
Vygon UsaLansdale, PA, United StatesSpecification developer6February 26, 2018030api.fda.gov
Vygon MFGDover, NH, United StatesManufacturer6February 26, 2018010api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesContract manufacturer, Manufacturer, Repackager or relabeler5November 30, 2023020api.fda.gov
L & Z Us, Inc.Norwood, NJ, United StatesManufacturer, Specification developer5December 1, 2023000api.fda.gov
PFM Medical, IncCarlsbad, CA, United StatesComplaint file establishment, Manufacturer3September 21, 2011010api.fda.gov
Biowy CorporationLake Forest, CA, United StatesManufacturer, Specification developer2April 30, 2020000api.fda.gov
Footprint Medical Inc.San Antonio, TX, United StatesManufacturer2June 3, 2013000api.fda.gov
Gamamed Vascular Systems Inc.Loveland, CO, United StatesManufacturer, Repackager or relabeler2March 8, 2013000api.fda.gov
Piccolo MedicalSan Francisco, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2November 17, 2025000api.fda.gov
Access Vascular, IncBillerica, MA, United StatesManufacturer1August 1, 2025030api.fda.gov
Arrow International LLC (subsidiary of Teleflex Incorporated)Morrisville, NC, United StatesManufacturer1December 22, 2016032api.fda.gov
Cardinal HealthHazelwood, MO, United StatesSpecification developer1November 5, 2013000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1July 18, 1996010api.fda.gov
Haolang Medical Usa CorporationClyde Hill, WA, United StatesSpecification developer1March 8, 2013000api.fda.gov
Health Line International CorporationSalt Lake City, UT, United StatesManufacturer1August 19, 2010000api.fda.gov
Utah Medical Products, Inc.Midvale, UT, United StatesManufacturer1September 25, 2000000api.fda.gov
Advantech CorporationMilpitas, CA, United StatesContract manufacturer0000api.fda.gov
Angiodynamics, Inc.Queensbury, NY, United StatesContract manufacturer0010api.fda.gov
Bard Shannon LimitedHumacao, PR, United StatesContract manufacturer0000api.fda.gov
Custom Wire Technologies, IncPort Washington, WI, United StatesContract manufacturer0000api.fda.gov
Dymax, Corp.Zelienople, PA, United StatesContract manufacturer0000api.fda.gov
Keystone ManufacturingKalamazoo, MI, United StatesContract manufacturer0000api.fda.gov
Martech Medical ProductsHarleysville, PA, United StatesContract manufacturer0000api.fda.gov
Medical Murray, Inc.Lake Zurich, IL, United StatesContract manufacturer0000api.fda.gov
Medron, LLCSalt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Nuwellis, Inc.Eden Prairie, MN, United StatesManufacturer, Specification developer0000api.fda.gov
Piccguard, LLCSheboygan, WI, United StatesManufacturer0000api.fda.gov
Point Medical Corp.Crown Point, IN, United StatesContract manufacturer0000api.fda.gov
Qualitel CorporationEverett, WA, United StatesContract manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 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.