Product code NWX

Device name

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

Medical specialty

Unknown

Device class

3

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset