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

Stent, Iliac

Unknown
FDA source (opens on fda.gov)

NIO is the FDA product code for Stent, Iliac, a class III device type. FDA's definition for this code reads: "Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
NIO
Device name
Stent, Iliac
FDA definition
Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
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
7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 29 companies shown, in name order