510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NIQClass III

Coronary Drug-Eluting Stent

Unknown
FDA source (opens on fda.gov)

NIQ is the FDA product code for Coronary Drug-Eluting Stent, a class III device type. FDA's definition for this code reads: "Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis". As of , FDA records hold no 510(k) clearances under this code and 6 recalls.

Classification record

Product code
NIQ
Device name
Coronary Drug-Eluting Stent
FDA definition
Stent, coronary, drug-eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the coronary artery or saphenous vein graft to maintain the lumen. The drug coating is intended to inhibit restenosis.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
6

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order