PNO
- Product code
- PNO
- Device name
- Catheter, Percutaneous, Cutting/Scoring
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1250
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 45 (all years; only the last 3 years are listed here)
FDA classification definition
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260012 | 2026-02-04 | Bard Peripheral Vascular, Inc. | UltraScore Focused Force PTA Balloon | |
| K243944 | 2025-04-22 | Goodman Co., Ltd. | Aperta NSE PTA Balloon Dilatation Catheter | |
| K242254 | 2025-04-21 | Dk Medical Technology Co., Ltd. | D·Kutting LL Peripheral Scoring Balloon Dilatation … | |
| K241478 | 2024-10-22 | Brosmed Medical Co., Ltd. | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | |
| K232258 | 2024-06-17 | Transit Scientific, LLC | XO Constrain Percutaneous Transluminal Angioplasty … | |
| K232013 | 2024-03-28 | Goodman Co., Ltd. | Aperta NSE PTA Balloon Dilatation Catheter (AW18-050… | |
| K232207 | 2024-03-07 | Dk Medical Technology Co., Ltd. | D·Kutting PTA Scoring Balloon Dilatation Catheter |
Official FDA classification page: PNO
Classification and pathway per current FDA publications. Data from openFDA (CC0).