← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS III

NIO — Stent, Iliac

Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen

DEVICE CLASS
Class III
MEDICAL SPECIALTY
Unknown
REVIEW PANEL
CV
✓ Implant✓ Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
pma: 9
0
RECALL ENTRIES

Recent clearances

P140002Terumo Medical Corporation · pma2026-07-16
P140030Biotronik AG · pma2026-06-22
P110035Boston Scientific Corp · pma2026-05-06
P940019Boston Scientific Scimed, Inc. · pma2026-05-06
P090003Boston Scientific Corporation · pma2026-05-06
P050017Cook Ireland, Ltd. · pma2026-04-14
P110043Abbott Vascular-Cardiac Therapies · pma2026-01-12
P020036Cordis US Corporation · pma2026-01-08

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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