Skip to the page

Data / Medical devices / Catheter, Angioplasty, Peripheral, Transluminal

Catheter, Angioplasty, Peripheral, Transluminal (LIT): 57 FDA-registered makers in 15 countries

57 establishments in 15 countries are registered with the FDA to make Catheter, Angioplasty, Peripheral, Transluminal (product code LIT, Class 2, 21 CFR 870.1250). 39 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 405 510(k) clearances under this code, the latest on September 21, 2026, and lists 29 recall events (1 Class I). FDA data exported November 3, 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
LIT
Device class
2
Regulation
870.1250
Medical specialty
Cardiovascular

Makers by country

CountryMakers
United States27
Ireland5
China5
Japan4
Mexico3
Costa Rica2
Malaysia2
Singapore2
Mauritius1
Canada1
Switzerland1
France1
Greece1
Czechia1
Dominican Republic1

Makers of Catheter, Angioplasty, Peripheral, Transluminal

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
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Specification developer14July 10, 2024000api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export14July 10, 2024000api.fda.gov
ev3, Inc.Plymouth, MN, United StatesManufacturer, Specification developer14December 15, 2021020api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer, Specification developer13July 10, 2024000api.fda.gov
Natec Medical LtdMoka, MauritiusContract manufacturer, Manufacturer9December 18, 2025000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesComplaint file establishment, Specification developer8January 20, 2023010api.fda.gov
Creagh Medical Ltd.Co. Galway Galway(County), IrelandComplaint file establishment, Manufacturer8November 15, 2024000api.fda.gov
Boston Scientific CorporationMaple Grove, MN, United StatesManufacturer, Manufacturer for export, Specification developer7July 10, 2024040api.fda.gov
Cordis US Corp.Miami Lakes, FL, United StatesComplaint file establishment, Specification developer7August 22, 2022060api.fda.gov
Abbott VascularTemecula, CA, United StatesComplaint file establishment, Manufacturer6February 13, 2026020api.fda.gov
Kaneka Corporation Osaka PlantSettsu-shi Osaka, JapanManufacturer6January 11, 2017000api.fda.gov
Abbott VascularSanta Clara, CA, United StatesSpecification developer5February 13, 2026000api.fda.gov
Medtronic Mexico S. de R.L. de CVTijuana Baja California, MexicoManufacturer5November 18, 2020000api.fda.gov
Numed Canada, Inc.CORNWALL Ontario, CanadaManufacturer5January 11, 2001000api.fda.gov
Numed, Inc.Hopkinton, NY, United StatesManufacturer5December 1, 2000010api.fda.gov
Brosmed Medical Co.,ltdDongguan Guangdong, ChinaContract manufacturer, Manufacturer, Specification developer4February 27, 2025010api.fda.gov
OrbusNeich Medical (Shenzhen) Co., Ltd.SHENZHEN Guangdong, ChinaComplaint file establishment, Manufacturer4June 11, 2024000api.fda.gov
Abbott VascularCLONMEL Tipperary, IrelandExporter to the US, Manufacturer3February 13, 2026000api.fda.gov
Clearstream Technologies Ltd.Wexford, IrelandContract manufacturer, Manufacturer3May 3, 2013000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer3February 13, 2017000api.fda.gov
Medtronic VascularDanvers, MA, United StatesSpecification developer3March 29, 1994011api.fda.gov
Mozarc Medical Us LLCMansfield, MA, United StatesSpecification developer3March 30, 2017000api.fda.gov
Verge Medical Inc.Campbell, CA, United StatesComplaint file establishment, Specification developer3May 8, 2015010api.fda.gov
Abbott VascularEl Coyol Alajuela, Costa RicaExporter to the US, Manufacturer2July 6, 2015000api.fda.gov
Biotronik AGBULACH Zurich, SwitzerlandExporter to the US, Manufacturer2April 4, 2025000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer2September 15, 2020010api.fda.gov
Boston Scientific Medical Device (Malaysia) SDN BHDTaman Perindustrian Batu Kawan Pulau Pinang, MalaysiaManufacturer2August 21, 2014000api.fda.gov
Contego Medical, IncRaleigh, NC, United StatesComplaint file establishment, Specification developer2June 9, 2022000api.fda.gov
Covidien LLCMansfield, MA, United StatesSpecification developer2March 30, 2017020api.fda.gov
Kossel Medtech (suzhou) Co., Ltd.Suzhou Jiangsu, ChinaManufacturer2December 20, 2023000api.fda.gov
Summa Therapeutics, LLCAllston, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2July 16, 2024010api.fda.gov
Curatia Medical Co.Sunnyvale, CA, United StatesSpecification developer1July 19, 2017000api.fda.gov
Curatia Medical LimitedSuzhou Jiangsu, ChinaManufacturer1July 19, 2017000api.fda.gov
DK Medical Technology Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1April 5, 2023000api.fda.gov
Micro Medical Solutions IncWoburn, MA, United StatesManufacturer1April 25, 2016000api.fda.gov
Medline Industries (NAMIC Division) - Glen FallsGlens Falls, NY, United StatesManufacturer, Repackager or relabeler1September 27, 1990000api.fda.gov
Nexstep MedicalDijon Cote-d'Or, FranceComplaint file establishment, Specification developer1January 15, 2020000api.fda.gov
Penumbra Inc.Roseville, CA, United StatesManufacturer1January 15, 2010000api.fda.gov
Rontis Hellas S.A.Larisa Thessalia, GreeceManufacturer1October 24, 2019000api.fda.gov
Arrow International CR, a.s.Hradec Kralove, CzechiaContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Bard Reynosa S.A. De C.V.REYNOSA Tamaulipas, MexicoContract manufacturer0000api.fda.gov
Biomerics FmiAthens, TX, United StatesContract manufacturer0000api.fda.gov
Biotronik Apm Pte. LtdSingapore South East, SingaporeContract manufacturer0000api.fda.gov
Brosmed Medical (malaysia) Sdn. Bhd.Simpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
C.R. Bard, Inc.Queensbury, NY, United StatesContract manufacturer0000api.fda.gov
Emerald Medical Services Pte. LtdSingapore North West, SingaporeContract manufacturer0000api.fda.gov
Minnesota Medtec, Inc.Maple Grove, MN, United StatesContract manufacturer0000api.fda.gov
Nipro Vascular CorporationNagoya Aichi, JapanManufacturer0000api.fda.gov
NIPRO VASCULAR CORPORATION Aichi FacilitySeto Aichi, JapanManufacturer0000api.fda.gov
NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation CenterSeto Aichi, JapanSpecification developer0000api.fda.gov
NYPRO DR, LLC (Building 52)Haina San Cristobal, Dominican RepublicContract manufacturer0000api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.El Coyol Alajuela, Costa RicaContract manufacturer0000api.fda.gov
Quasar MED IE (QIE) LimitedGalway Connaught, IrelandContract manufacturer0000api.fda.gov
Springboard ManufacturingRancho Cordova, CA, United StatesContract manufacturer0000api.fda.gov
Sterigenics U.S., LLCQueensbury, NY, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Synergy Health AST, LLCSan Diego, CA, United StatesManufacturer for export0000api.fda.gov

Updated September 21, 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.