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NIVHumanitarian device exemption

Coronary Covered Stent

Unknown
FDA source (opens on fda.gov)

NIV is the FDA product code for Coronary Covered Stent. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NIV
Device name
Coronary Covered Stent
FDA 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.
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code