510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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OUTClass III

Intracranial Aneurysm Flow Diverter

Unknown
FDA source (opens on fda.gov)

OUT is the FDA product code for Intracranial Aneurysm Flow Diverter, a class III device type. FDA's definition for this code reads: "Treatment of wide-necked and larger or giant intracranial aneurysms". As of , FDA records hold no 510(k) clearances under this code and 13 recalls.

Classification record

Product code
OUT
Device name
Intracranial Aneurysm Flow Diverter
FDA definition
Treatment of wide-necked and larger or giant intracranial aneurysms.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
14

Companies listing this code with FDA

Companies whose registered establishments list this code