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

Intracranial Neurovascular Stent

Unknown
FDA source (opens on fda.gov)

NJE is the FDA product code for Intracranial Neurovascular Stent. FDA's definition for this code reads: "An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use". As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
NJE
Device name
Intracranial Neurovascular Stent
FDA definition
An intracranial neurovascular stent is a tubular device placed in the blood vessel of the intracranial cavity to treat a vascular abnormality. It differs from other stents in that it is intended for intracranial use.
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
No
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