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 Angioscore, Inc., Cagent Vascular, LLC and Goodman Co., Ltd..

47
Total
47
Cleared
106d
Avg days
2004
Since
Growing category - 5 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 152d recently vs 100d historically

FDA 510(k) Cleared Catheter, Percutaneous, Cutting/scoring Devices (Product Code PNO)

47 devices
1–24 of 47
Cleared Oct 22, 2026
Zylox PanFlex Percutaneous Transluminal Angioplasty Scoring Catheter
K260686
Zylox Medtech Co., Ltd.
Cardiovascular · 233d
Cleared Sep 16, 2026
JADE SCORE PTA Scoring Balloon Dilatation Catheter
K261778
OrbusNeich Medical (Shenzhen) Co., Ltd.
Cardiovascular · 110d
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 Sep 22, 2017
ULTRASCORE Focused Force PTA Balloon
K172571
C. R. Bard
Cardiovascular · 25d
Cleared Jun 14, 2017
UltraScore Focused Force PTA Balloon
K163420
Bard Peripheral Vascular, Inc.
Cardiovascular · 190d
Cleared Feb 13, 2017
Serranator Alto PTA Serration Balloon Catheter
K163380
Cagent Vascular, LLC
Cardiovascular · 74d
Cleared May 25, 2016
FLEX SCORING CATHETER
K152789
Venturemed Group
Cardiovascular · 243d
Cleared Jun 10, 2015
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter
K151253
Boston Scientific Limited
Cardiovascular · 29d
Cleared Apr 08, 2015
AngioSculpt PTA Scoring Baloon Catheters
K150634
Spectranetrics
Cardiovascular · 28d
Cleared Mar 27, 2015
ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER
K141322
Cook Incorporated
Cardiovascular · 311d

About Product Code PNO - Regulatory Context

510(k) Submission Activity

47 total 510(k) submissions under product code PNO since 2004, with 47 receiving FDA clearance (average review time: 106 days).

Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - PNO Product Code

Recent submissions under PNO have taken an average of 152 days to reach a decision - up from 100 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 →