PNO · Class II · 21 CFR 870.1250

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, Transit Scientific, LLC and Goodman Co., Ltd..

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
1–24 of 45
Cleared Feb 04, 2026
UltraScore™ Focused Force PTA Balloon
K260012
Bard Peripheral Vascular, Inc.
Cardiovascular · 30d
Cleared Apr 22, 2025
Aperta NSE PTA Balloon Dilatation Catheter
K243944
Goodman Co., Ltd.
Cardiovascular · 123d
Cleared Apr 21, 2025
D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter
K242254
Dk Medical Technology Co., Ltd.
Cardiovascular · 264d
Cleared Oct 22, 2024
Tri-Wedge PTA Scoring Balloon Dilatation Catheter
K241478
Brosmed Medical Co., Ltd.
Cardiovascular · 151d
Cleared Jun 17, 2024
XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter
K232258
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)
K232013
Goodman Co., Ltd.
Cardiovascular · 266d
Cleared Mar 07, 2024
D·Kutting™ PTA Scoring Balloon Dilatation Catheter
K232207
Dk Medical Technology Co., Ltd.
Cardiovascular · 225d
Cleared Oct 18, 2022
XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter
K221986
Transit Scientific, LLC
Cardiovascular · 104d
Cleared May 04, 2022
Serranator PTA Serration Balloon Catheter
K220704
Cagent Vascular, LLC
Cardiovascular · 55d
Cleared Dec 15, 2021
Serranator PTA Serration Balloon Catheter
K213728
Cagent Vascular, LLC
Cardiovascular · 19d
Cleared Dec 22, 2020
Serranator PTA Serration Balloon Catheter
K203437
Cagent Vascular, LLC
Cardiovascular · 29d
Cleared Sep 11, 2020
FLEX Vessel Prep System
K202187
Venturemed Group, Inc.
Cardiovascular · 38d
Cleared May 29, 2020
XO Score Percutaneous Transluminal Angioplasty Scoring Catheter
K193495
Transit Scientific
Cardiovascular · 164d
Cleared Apr 15, 2020
Serranator PTA Serration Balloon Catheter
K193181
Cagent Vascular, LLC
Cardiovascular · 149d
Cleared Jun 11, 2019
Scoreflex PTA Scoring Balloon Catheter
K182713
Orbusneich Medical Trading, Inc.
Cardiovascular · 257d
Cleared Dec 13, 2010
VASCUTRAK PTA DILATATION CATHETER
K103459
C.R. Bard, Inc.
Cardiovascular · 19d
Cleared Jul 01, 2004
PERIPHERAL CUTTING BALLOON
K040155
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 →