PNO · Catheter, Percutaneous, Cutting/Scoring
Cardiovascular · 21 CFR 870.1250 · Class 2
Overview
| Product Code | PNO |
|---|---|
| Device Name | Catheter, Percutaneous, Cutting/Scoring |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260012 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Feb 4, 2026 | SESE |
| K243944 | Aperta NSE PTA Balloon Dilatation Catheter | Goodman Co., Ltd. | Apr 22, 2025 | SESE |
| K242254 | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Apr 21, 2025 | SESE |
| K241478 | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | Brosmed Medical Co., Ltd. | Oct 22, 2024 | SESE |
| K232258 | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | Transit Scientific, LLC | Jun 17, 2024 | SESE |
| K232013 | 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. | Mar 28, 2024 | SESE |
| K232207 | D·Kutting PTA Scoring Balloon Dilatation Catheter | Dk Medical Technology Co., Ltd. | Mar 7, 2024 | SESE |
| K221986 | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter | Transit Scientific, LLC | Oct 18, 2022 | SESE |
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | May 4, 2022 | SESE |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Dec 15, 2021 | SESE |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Dec 22, 2020 | SESE |
| K202187 | FLEX Vessel Prep System | Venturemed Group, Inc. | Sep 11, 2020 | SESE |
| K193495 | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | Transit Scientific | May 29, 2020 | SESE |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | Apr 15, 2020 | SESE |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | Jun 11, 2019 | SESE |
| K172571 | ULTRASCORE Focused Force PTA Balloon | C. R. Bard | Sep 22, 2017 | SESE |
| K163420 | UltraScore Focused Force PTA Balloon | Bard Peripheral Vascular, Inc. | Jun 14, 2017 | SESE |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | Feb 13, 2017 | SESE |
| K152789 | FLEX SCORING CATHETER | Venturemed Group | May 25, 2016 | SESE |
| K151253 | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | Boston Scientific Limited | Jun 10, 2015 | SESE |
Top Applicants
- Angioscore, Inc. — 13 clearances
- Cagent Vascular, LLC — 5 clearances
- Bard Peripheral Vascular, Inc. — 2 clearances
- Boston Scientific — 2 clearances
- Boston Scientific Ivt — 2 clearances
