PNO — Catheter, Percutaneous, Cutting/Scoring Class II
FDA product code PNO covers "Catheter, Percutaneous, Cutting/Scoring", a Class II medical device regulated under 21 CFR 870.1250. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261778 | orbusneich medical (shenzhen) co | JADE SCORE PTA Scoring Balloon Dilatation Catheter | September 16, 2026 |
| 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 |