FDA product code OZH: Transcatheter Septal Occluder (Ventricular)
OZH is the FDA product code for transcatheter septal occluder (ventricular). It is a Class III device, reviewed by the Cardiovascular panel. Devices under OZH reach the market by PMA; FDA lists no cleared 510(k)s for it.
Definition
For the treatment of defect in the ventricular septum and closure of ventricular septal defects via transcatheter technique.
Classification
| Field | Value |
|---|---|
| Device name | Transcatheter Septal Occluder (Ventricular) |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OZH devices
openFDA lists no recalls for product code OZH.
Frequently asked questions
What is FDA product code OZH?
OZH is the FDA product code for transcatheter septal occluder (ventricular). It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OZH?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OZH
- Run a recall and safety report across every OZH manufacturer
- Watch product code OZH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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