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.
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- Product code
- LIT
- Device class
- 2
- Regulation
- 870.1250
- Medical specialty
- Cardiovascular
Makers by country
| Country | Makers |
|---|---|
| United States | 27 |
| Ireland | 5 |
| China | 5 |
| Japan | 4 |
| Mexico | 3 |
| Costa Rica | 2 |
| Malaysia | 2 |
| Singapore | 2 |
| Mauritius | 1 |
| Canada | 1 |
| Switzerland | 1 |
| France | 1 |
| Greece | 1 |
| Czechia | 1 |
| Dominican Republic | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Saint Paul, MN, United States | Complaint file establishment, Specification developer | 14 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer, Manufacturer for export | 14 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| ev3, Inc. | Plymouth, MN, United States | Manufacturer, Specification developer | 14 | December 15, 2021 | 0 | 2 | 0 | api.fda.gov |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | Manufacturer, Specification developer | 13 | July 10, 2024 | 0 | 0 | 0 | api.fda.gov |
| Natec Medical Ltd | Moka, Mauritius | Contract manufacturer, Manufacturer | 9 | December 18, 2025 | 0 | 0 | 0 | api.fda.gov |
| Bard Peripheral Vascular, Inc. | Tempe, AZ, United States | Complaint file establishment, Specification developer | 8 | January 20, 2023 | 0 | 1 | 0 | api.fda.gov |
| Creagh Medical Ltd. | Co. Galway Galway(County), Ireland | Complaint file establishment, Manufacturer | 8 | November 15, 2024 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Manufacturer for export, Specification developer | 7 | July 10, 2024 | 0 | 4 | 0 | api.fda.gov |
| Cordis US Corp. | Miami Lakes, FL, United States | Complaint file establishment, Specification developer | 7 | August 22, 2022 | 0 | 6 | 0 | api.fda.gov |
| Abbott Vascular | Temecula, CA, United States | Complaint file establishment, Manufacturer | 6 | February 13, 2026 | 0 | 2 | 0 | api.fda.gov |
| Kaneka Corporation Osaka Plant | Settsu-shi Osaka, Japan | Manufacturer | 6 | January 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 5 | February 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 5 | November 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Numed Canada, Inc. | CORNWALL Ontario, Canada | Manufacturer | 5 | January 11, 2001 | 0 | 0 | 0 | api.fda.gov |
| Numed, Inc. | Hopkinton, NY, United States | Manufacturer | 5 | December 1, 2000 | 0 | 1 | 0 | api.fda.gov |
| Brosmed Medical Co.,ltd | Dongguan Guangdong, China | Contract manufacturer, Manufacturer, Specification developer | 4 | February 27, 2025 | 0 | 1 | 0 | api.fda.gov |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | SHENZHEN Guangdong, China | Complaint file establishment, Manufacturer | 4 | June 11, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abbott Vascular | CLONMEL Tipperary, Ireland | Exporter to the US, Manufacturer | 3 | February 13, 2026 | 0 | 0 | 0 | api.fda.gov |
| Clearstream Technologies Ltd. | Wexford, Ireland | Contract manufacturer, Manufacturer | 3 | May 3, 2013 | 0 | 0 | 0 | api.fda.gov |
| Cook Incorporated | Bloomington, IN, United States | Complaint file establishment, Manufacturer | 3 | February 13, 2017 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Vascular | Danvers, MA, United States | Specification developer | 3 | March 29, 1994 | 0 | 1 | 1 | api.fda.gov |
| Mozarc Medical Us LLC | Mansfield, MA, United States | Specification developer | 3 | March 30, 2017 | 0 | 0 | 0 | api.fda.gov |
| Verge Medical Inc. | Campbell, CA, United States | Complaint file establishment, Specification developer | 3 | May 8, 2015 | 0 | 1 | 0 | api.fda.gov |
| Abbott Vascular | El Coyol Alajuela, Costa Rica | Exporter to the US, Manufacturer | 2 | July 6, 2015 | 0 | 0 | 0 | api.fda.gov |
| Biotronik AG | BULACH Zurich, Switzerland | Exporter to the US, Manufacturer | 2 | April 4, 2025 | 0 | 0 | 0 | api.fda.gov |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 2 | September 15, 2020 | 0 | 1 | 0 | api.fda.gov |
| Boston Scientific Medical Device (Malaysia) SDN BHD | Taman Perindustrian Batu Kawan Pulau Pinang, Malaysia | Manufacturer | 2 | August 21, 2014 | 0 | 0 | 0 | api.fda.gov |
| Contego Medical, Inc | Raleigh, NC, United States | Complaint file establishment, Specification developer | 2 | June 9, 2022 | 0 | 0 | 0 | api.fda.gov |
| Covidien LLC | Mansfield, MA, United States | Specification developer | 2 | March 30, 2017 | 0 | 2 | 0 | api.fda.gov |
| Kossel Medtech (suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 2 | December 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Summa Therapeutics, LLC | Allston, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | July 16, 2024 | 0 | 1 | 0 | api.fda.gov |
| Curatia Medical Co. | Sunnyvale, CA, United States | Specification developer | 1 | July 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| Curatia Medical Limited | Suzhou Jiangsu, China | Manufacturer | 1 | July 19, 2017 | 0 | 0 | 0 | api.fda.gov |
| DK Medical Technology Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | April 5, 2023 | 0 | 0 | 0 | api.fda.gov |
| Micro Medical Solutions Inc | Woburn, MA, United States | Manufacturer | 1 | April 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Medline Industries (NAMIC Division) - Glen Falls | Glens Falls, NY, United States | Manufacturer, Repackager or relabeler | 1 | September 27, 1990 | 0 | 0 | 0 | api.fda.gov |
| Nexstep Medical | Dijon Cote-d'Or, France | Complaint file establishment, Specification developer | 1 | January 15, 2020 | 0 | 0 | 0 | api.fda.gov |
| Penumbra Inc. | Roseville, CA, United States | Manufacturer | 1 | January 15, 2010 | 0 | 0 | 0 | api.fda.gov |
| Rontis Hellas S.A. | Larisa Thessalia, Greece | Manufacturer | 1 | October 24, 2019 | 0 | 0 | 0 | api.fda.gov |
| Arrow International CR, a.s. | Hradec Kralove, Czechia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 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 Fmi | Athens, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biotronik Apm Pte. Ltd | Singapore South East, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Brosmed Medical (malaysia) Sdn. Bhd. | Simpang Ampat Pulau Pinang, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Emerald Medical Services Pte. Ltd | Singapore North West, Singapore | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Minnesota Medtec, Inc. | Maple Grove, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nipro Vascular Corporation | Nagoya Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NIPRO VASCULAR CORPORATION Aichi Facility | Seto Aichi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NIPRO VASCULAR CORPORATION Seto Facility / NIPRO VASCULAR CORPORATION Innovation Center | Seto Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NYPRO DR, LLC (Building 52) | Haina San Cristobal, Dominican Republic | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nitinol Devices & Components Costa Rica, S. R. L. | El Coyol Alajuela, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quasar MED IE (QIE) Limited | Galway Connaught, Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Springboard Manufacturing | Rancho Cordova, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sterigenics U.S., LLC | Queensbury, NY, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, LLC | San Diego, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.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.