Data / Medical devices / Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Drug-Eluting Peripheral Transluminal Angioplasty Catheter (ONU): 20 FDA-registered makers in 4 countries
20 establishments in 4 countries are registered with the FDA to make Drug-Eluting Peripheral Transluminal Angioplasty Catheter (product code ONU, Class 3). 11 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- ONU
- Device class
- 3
- Medical specialty
- Unknown
Makers by country
| Country | Makers |
|---|---|
| United States | 14 |
| Ireland | 4 |
| Netherlands | 1 |
| Germany | 1 |
Makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter
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 | 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 | |
| Boston Scientific International BV, European Dist. Ctr. | KERKRADE Limburg, Netherlands | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Boston Scientific Limited | GALWAY Galway(County), Ireland | 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 Ireland | GALWAY Galway(County), Ireland | Manufacturer | 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 | |
| Store-All Logistics Ltd | Slieverue Kilkenny, Ireland | 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 | |
| Creagh Medical Ltd. | Co. Galway Galway(County), Ireland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Freudenberg Medical Hemoteq | Wurselen North Rhine-Westphalia, Germany | Contract manufacturer | 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.