Data / Medical devices / United States / Lutonix, Inc.
Lutonix, Inc.: FDA-registered device maker in Tempe, AZ, United States, 2 PMA approvals
Lutonix, Inc. is registered with the FDA (registration 3006513822) in Tempe, AZ, United States. It lists 3 device types. The FDA files 2 PMA approvals under its listings, the newest dated August 25, 2017. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3006513822
- Address
- 1625 West 3rd Street, Tempe, AZ, United States, 85281
- Owner or operator
- C. R. Bard, Inc. (2212754)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- October 16, 2014
- Registered through
- 2027
- Brand names listed
- Lutonix 014 Drug Coated Balloon PTA Catheter, Lutonix 014 PTCA Drug Coated Balloon Catheter, Lutonix 018 Drug Coated Balloon PTA Catheter, Lutonix 035 Drug Coated Balloon PTA Catheter, Lutonix Drug Coated Balloon
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | 2 | Manufacturer for export | accessdata.fda.gov |
| Drug-Coated Peripheral Transluminal Angioplasty Catheter | PRC | 3 | Manufacturer | accessdata.fda.gov |
| Drug-Eluting Peripheral Transluminal Angioplasty Catheter | ONU | 3 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| August 25, 2017 | P170003 | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 | PRC | 24 | July 9, 2026 | accessdata.fda.gov |
| October 9, 2014 | P130024 | LUTONIX DRUG COATED BALLOON PTA CATETER | ONU | 41 | July 9, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Drug-Coated Peripheral Transluminal Angioplasty Catheter
- All makers of Catheters, Transluminal Coronary Angioplasty, Percutaneous
- All makers of Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Updated July 9, 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.