NIV

Coronary Covered Stent

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: NIV
Classification and pathway per current FDA publications. Data from openFDA (CC0).