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

Intracranial Coil-Assist Stent

Unknown
FDA source (opens on fda.gov)

QCA is the FDA product code for Intracranial Coil-Assist Stent, a class III device type. FDA's definition for this code reads: "An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck intracranial aneurysms". As of , FDA records hold no 510(k) clearances under this code and 2 recalls.

Classification record

Product code
QCA
Device name
Intracranial Coil-Assist Stent
FDA definition
An intracranial coil-assist stent is a tubular device placed in an artery in the brain to assist in the placement and retention of embolic coils for the treatment of wide-neck 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
2

Companies listing this code with FDA

Companies whose registered establishments list this code