FDA Product Code PNO: Catheter, Percutaneous, Cutting/scoring
To Reduce Vascular Stenosis By Dilatation And Apposition Of The Cutting/scoring Surfaces To The Stenotic Material
Leading manufacturers include Goodman Co., Ltd., Dk Medical Technology Co., Ltd. and Transit Scientific, LLC.
FDA 510(k) Cleared Catheter, Percutaneous, Cutting/scoring Devices (Product Code PNO)
About Product Code PNO - Regulatory Context
510(k) Submission Activity
45 total 510(k) submissions under product code PNO since 2004, with 45 receiving FDA clearance (average review time: 103 days).
Submission volume has increased in recent years - 5 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PNO have taken an average of 178 days to reach a decision - up from 94 days historically. Manufacturers should account for longer review timelines in current project planning.
PNO devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →