Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
The Catheter, Percutaneous Transluminal Coronary Angioplasty (PTCA), Cutting/Scoring (product code NWX) is a specialized interventional cardiology catheter designed to reduce coronary artery stenosis by dilating a balloon and applying cutting or scoring surfaces to stenotic material, thereby improving myocardial perfusion. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA) to demonstrate safety and effectiveness. The device is reviewed by the Cardiovascular panel and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NWX
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 12 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 12 registration numbers. Click on an entry to view related FDA registrations.