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

Transcatheter Septal Occluder (Ventricular)

Unknown
FDA source (opens on fda.gov)

OZH is the FDA product code for Transcatheter Septal Occluder (Ventricular), a class III device type. FDA's definition for this code reads: "For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OZH
Device name
Transcatheter Septal Occluder (Ventricular)
FDA definition
For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique.
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code