FDA product code NIU

Stent, Superficial Femoral Artery, Drug-Eluting

Unknown·Class 3·21 CFR ·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NIU
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
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Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
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.

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About this record

Stent, Superficial Femoral Artery, Drug-Eluting is a medical device type in the Unknown specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.