NIV
- Product code
- NIV
- Device name
- Coronary Covered Stent
- Device class
- Class F
- Medical specialty
- Unknown
- Marketing pathway
- HDE - Humanitarian Device Exemption
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification definition
Stent, coronary, covered -- a metal scaffold covered with material placed via a delivery catheter into the coronary artery artery or saphenous vein graft for the treatment of free perforations and/or to prevent dislodgement into the circulation of biological material from the vascular wall during or following placement of the device.
Official FDA classification page: NIV
Classification and pathway per current FDA publications. Data from openFDA (CC0).