PNOClass II

Catheter, Percutaneous, Cutting/Scoring

21 CFR 870.1250 / Cardiovascular

PNO is the FDA product code for Catheter, Percutaneous, Cutting/Scoring, a class II device type, regulated under 21 CFR 870.1250. FDA's definition for this code reads: "To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material". As of 2026-09-10, FDA records hold 45 510(k) clearances under this code, the most recent dated 2026-02-04, and 3 recalls.

Classification record

Product code: PNO
Device name: Catheter, Percutaneous, Cutting/Scoring
FDA definition: To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Regulation: 21 CFR 870.1250
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 46
Ingested recalls: 3

Clearances, product code PNO

By decision year

46 clearances under product code PNO with a decision year between 2004 and 2026, 2008 the highest year at 4.

Show the numbers

510(k) clearances under FDA product code PNO by decision year
Year	Clearances
2004	2
2005	2
2006	2
2007	3
2008	4
2009	1
2010	3
2011	2
2012	1
2013	1
2014	1
2015	4
2016	1
2017	3
2019	1
2020	4
2021	1
2022	2
2024	4
2025	2
2026	2

Applicants with the most clearances

Product code PNO

Applicants holding the most 510(k) clearances under product code PNO
Applicant	Clearances
Spectranetics Corp.	13
Cagent Vascular	5
Boston Scientific Corporation	4
Transit Scientific, LLC	3
Bard Peripheral Vascular Inc	2
Boston Scientific Ivt	2
DK Medical Technology Co., Ltd.	2
Goodman Co., Ltd.	2
VENTUREMED GROUP, Inc	2
Ymed, Inc.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order