FDA Product Code PNO: Catheter, Percutaneous, Cutting/scoring
To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
Leading manufacturers include Cagent Vascular, LLC, Boston Scientific and Transit Scientific, LLC.
45
Total
45
Cleared
103d
Avg days
2004
Since
Stable submission activity - 4 submissions in the last 2 years
Review times increasing: avg
142d
recently vs 99d historically
FDA 510(k) Cleared Catheter, Percutaneous, Cutting/scoring Devices (Product Code PNO)
45 devices
Cleared
Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
Bard Peripheral Vascular, Inc.
Cardiovascular
30d
Cleared
Apr 22, 2025
Aperta NSE PTA Balloon Dilatation Catheter
Goodman Co., Ltd.
Cardiovascular
123d
Cleared
Apr 21, 2025
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
Dk Medical Technology Co., Ltd.
Cardiovascular
264d
Cleared
Oct 22, 2024
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
Brosmed Medical Co., Ltd.
Cardiovascular
151d
Cleared
Jun 17, 2024
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
Transit Scientific, LLC
Cardiovascular
322d
Cleared
Mar 28, 2024
Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040)
Goodman Co., Ltd.
Cardiovascular
266d
Cleared
Mar 07, 2024
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
Dk Medical Technology Co., Ltd.
Cardiovascular
225d
Cleared
Oct 18, 2022
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
Transit Scientific, LLC
Cardiovascular
104d
Cleared
May 04, 2022
Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC
Cardiovascular
55d
Cleared
Dec 15, 2021
Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC
Cardiovascular
19d
Cleared
Dec 22, 2020
Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC
Cardiovascular
29d
Cleared
Sep 11, 2020
FLEX Vessel Prep System
Venturemed Group, Inc.
Cardiovascular
38d
Cleared
May 29, 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
Transit Scientific
Cardiovascular
164d
Cleared
Apr 15, 2020
Serranator PTA Serration Balloon Catheter
Cagent Vascular, LLC
Cardiovascular
149d
Cleared
Jun 11, 2019
Scoreflex PTA Scoring Balloon Catheter
Orbusneich Medical Trading, Inc.
Cardiovascular
257d
Cleared
Mar 27, 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
Cook Incorporated
Cardiovascular
311d
Cleared
Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
C.R. Bard, Inc.
Cardiovascular
19d
Cleared
Jun 04, 2007
2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS
Boston Scientific
Cardiovascular
61d
Cleared
Oct 05, 2006
SMALL PERIPHERAL CUTTING BALLON, MONORAIL DELIVERY SYSTEM
Boston Scientific
Cardiovascular
51d
Cleared
Jul 01, 2004
PERIPHERAL CUTTING BALLOON
Boston Scientific Corp
Cardiovascular
160d
About Product Code PNO - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code PNO since 2004, with 45 receiving FDA clearance (average review time: 103 days).
Submission volume has remained relatively stable over the observed period, with 4 submissions in the last 24 months.
FDA 510(k) Review Time - PNO Product Code
Recent submissions under PNO have taken an average of 142 days to reach a decision - up from 99 days historically. Manufacturers should account for longer review timelines in current project planning.
PNO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →