PNO

Catheter, Percutaneous, Cutting/Scoring

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

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (7)

Last three years. Most recent: 2026-02-04.

NumberDecision dateApplicantDevice nameSummary
K2600122026-02-04Bard Peripheral Vascular, Inc.UltraScore™ Focused Force PTA BalloonPDF
K2439442025-04-22Goodman Co., Ltd.Aperta NSE PTA Balloon Dilatation CatheterPDF
K2422542025-04-21Dk Medical Technology Co., Ltd.D·Kutting™ LL Peripheral Scoring Balloon Dilatation …PDF
K2414782024-10-22Brosmed Medical Co., Ltd.Tri-Wedge PTA Scoring Balloon Dilatation CatheterPDF
K2322582024-06-17Transit Scientific, LLCXO Constrain™ Percutaneous Transluminal Angioplasty …PDF
K2320132024-03-28Goodman Co., Ltd.Aperta NSE PTA Balloon Dilatation Catheter (AW18-050…PDF
K2322072024-03-07Dk Medical Technology Co., Ltd.D·Kutting™ PTA Scoring Balloon Dilatation CatheterPDF

7 summaries are archived here for direct download.

Official FDA classification page: PNO
Classification and pathway per current FDA publications. Data from openFDA (CC0).