DeviceClearance

Product code PNO— Cardiovascular

ANGIOSCULPT PTA SCORING BALLOON CATHETER

Classification name
Catheter, Percutaneous, Cutting/Scoring
Device class
Class 2
Regulation
21 CFR 870.1250
Advisory panel
Cardiovascular
Total cleared
45
First cleared
Most recent

FDA classification definition

“To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material”

— U.S. Food and Drug Administration, device classification record for product code PNO under 21 CFR 870.1250, via openFDA

Market context for product code PNO

FDA has cleared 45 devices under product code PNO between 2004 and 2026, filed by 22 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code PNO

Adverse events under product code PNO

product code PNO
Malfunction
1,646
Total
1,646

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code PNO

Data sourced from openFDA. This site is unofficial and independent of the FDA.