PNO — Catheter, Percutaneous, Cutting/Scoring Class II
Classification Details
- Product Code
- PNO
- Device Class
- Class II
- Regulation Number
- 870.1250
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260012 | bard peripheral vascular | UltraScore Focused Force PTA Balloon | February 4, 2026 |
| K243944 | goodman co | Aperta NSE PTA Balloon Dilatation Catheter | April 22, 2025 |
| K242254 | dk medical technology co | D·Kutting LL Peripheral Scoring Balloon Dilatation Catheter | April 21, 2025 |
| K241478 | brosmed medical co | Tri-Wedge PTA Scoring Balloon Dilatation Catheter | October 22, 2024 |
| K232258 | transit scientific | XO Constrain Percutaneous Transluminal Angioplasty Constraining Catheter | June 17, 2024 |
| K232013 | goodman co | Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09 | March 28, 2024 |
| K232207 | dk medical technology co | D·Kutting PTA Scoring Balloon Dilatation Catheter | March 7, 2024 |
| K221986 | transit scientific | XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP | October 18, 2022 |
| K220704 | cagent vascular | Serranator PTA Serration Balloon Catheter | May 4, 2022 |
| K213728 | cagent vascular | Serranator PTA Serration Balloon Catheter | December 15, 2021 |
| K203437 | cagent vascular | Serranator PTA Serration Balloon Catheter | December 22, 2020 |
| K202187 | venturemed group | FLEX Vessel Prep System | September 11, 2020 |
| K193495 | transit scientific | XO Score Percutaneous Transluminal Angioplasty Scoring Catheter | May 29, 2020 |
| K193181 | cagent vascular | Serranator PTA Serration Balloon Catheter | April 15, 2020 |
| K182713 | orbusneich medical trading | Scoreflex PTA Scoring Balloon Catheter | June 11, 2019 |
| K172571 | c. r. bard | ULTRASCORE Focused Force PTA Balloon | September 22, 2017 |
| K163420 | bard peripheral vascular | UltraScore Focused Force PTA Balloon | June 14, 2017 |
| K163380 | cagent vascular | Serranator Alto PTA Serration Balloon Catheter | February 13, 2017 |
| K152789 | venturemed group | FLEX SCORING CATHETER | May 25, 2016 |
| K151253 | boston scientific limited | 2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter | June 10, 2015 |