← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NIQ — Coronary Drug-Eluting Stent

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
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
6
510(K)/PMA CLEARANCES
pma: 6
0
RECALL ENTRIES

Recent clearances

P170030Biotronik AG · pma2026-06-11
P160043Medtronic Vascular · pma2026-06-05
P110019Abbott Vascular · pma2026-05-22
P170008Medinol, Ltd. · pma2026-03-26
P150003Boston Scientific Corporation · pma2025-10-29
P110010Boston Scientific Corp · pma2025-01-14

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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