NIUClass III

Stent, Superficial Femoral Artery, Drug-Eluting

Unknown

NIU is the FDA product code for Stent, Superficial Femoral Artery, Drug-Eluting, a class III device type. FDA's definition for this code reads: "Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and 3 recalls.

Classification record

Product code: NIU
Device name: Stent, Superficial Femoral Artery, Drug-Eluting
FDA definition: Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery 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: 3

Companies listing this code with FDA

Companies whose registered establishments list this code

Recent clearances

Product code NIU

FDA records hold no clearances under product code NIU.

Recent recalls

Product code NIU

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)