Product code PNO

Device name

Catheter, Percutaneous, Cutting/Scoring

Medical specialty

Cardiovascular

Device class

2

Regulation number

870.1250

Review panel

CV

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material

Source

FDA openFDA device classification dataset