NWX — Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Class III
FDA product code NWX covers "Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring", a Class III medical device. Submissions are reviewed by the Unknown panel.
Classification Details
- Product Code
- NWX
- Device Class
- Class III
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- No
Definition
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.