Data / Medical devices / Drug-Eluting Peripheral Transluminal Angioplasty Catheter / United States
FDA-registered makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter in the United States: 14 establishments
14 establishments in the United States are registered with the FDA to make Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU). 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Drug-Eluting Peripheral Transluminal Angioplasty Catheter
- Product code
- ONU
- Country
- United States
Makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Boston Scientific Corporation | Maple Grove, MN, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corp., Marina Bay Cust. Fulfillment Center | Quincy, MA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Corporation | Coventry, RI, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Lutonix, Inc. | Tempe, AZ, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Vascular | Santa Rosa, CA, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Philips Image Guided Therapy Corporation | Plymouth, MN, United States | Complaint file establishment, Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Surmodics, Inc. | Eden Prairie, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| C.R. Bard, Inc. | Queensbury, NY, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isomedix Operations, Inc. | Minneapolis, MN, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medalliance, LLC | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| MicroVention, Inc. | Aliso Viejo, CA, United States | Manufacturer for export | 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 | Petaluma, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Synergy Health AST, LLC | San Diego, CA, United States | Contract sterilizer, Manufacturer for export | 0 | 0 | 0 | 0 | api.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.