FDA product code ONU: Drug-Eluting Peripheral Transluminal Angioplasty Catheter
ONU is the FDA product code for drug-eluting peripheral transluminal angioplasty catheter. It is a Class III device, reviewed by the Cardiovascular panel. Devices under ONU reach the market by PMA; FDA lists no cleared 510(k)s for it. 6 PMA applications cite this product code. FDA has posted 1 recall for ONU devices, 1 initiated in the last five years.
Definition
A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, femoral, and iliofemoral.
Classification
| Field | Value |
|---|---|
| Device name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for ONU devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-03-23.
| Year | Recalls |
|---|---|
| 2022 | 1 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- C9602 — Percutaneous transluminal coronary atherectomy, with drug eluting intracoronary stent, with coronary angioplasty when performed; single major coronary artery or branch
Frequently asked questions
What is FDA product code ONU?
ONU is the FDA product code for drug-eluting peripheral transluminal angioplasty catheter. It is a Class III device, reviewed by the Cardiovascular panel.
What device class is ONU?
Class III. Typical premarket route: PMA.
Have ONU devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code ONU
- Run a recall and safety report across every ONU manufacturer
- Watch product code ONU for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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