NWX · Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
· Class 3
Overview
| Product Code | NWX |
|---|---|
| Device Name | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
| Device Class | Class 3 |
| Review Panel |
Identification
To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P230026 | Lacrosse NSE ALPHA Coronary Dilatation Catheter | Goodman Co., Ltd. | Jun 6, 2024 | APPR |
| P200041 | Scoreflex NC Scoring PTCA Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | Dec 21, 2021 | APPR |
| P050018 | ANGIOSCULPT SCORING BALLOON CATHETER | Spectranetics Corp. | Jan 8, 2007 | APPR |
| P950020 | FLEXATOME CUTTING BALLOON | Boston Scientific Corp | Apr 18, 2000 | APPR |
Top Applicants
- Boston Scientific Corp — 1 clearance
- Goodman Co., Ltd. — 1 clearance
- OrbusNeich Medical (Shenzhen) Co., Ltd. — 1 clearance
- Spectranetics Corp. — 1 clearance
