FDA product code OZG: Transcatheter Septal Occluder (Atrial)
OZG is the FDA product code for transcatheter septal occluder (atrial). It is a Class III device, reviewed by the Cardiovascular panel. Devices under OZG reach the market by PMA; FDA lists no cleared 510(k)s for it. 1 PMA application cites this product code.
Definition
For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
Classification
| Field | Value |
|---|---|
| Device name | Transcatheter Septal Occluder (Atrial) |
| Device class | Class III |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | PMA |
| Implant | Yes |
Recalls for OZG devices
openFDA lists no recalls for product code OZG.
Frequently asked questions
What is FDA product code OZG?
OZG is the FDA product code for transcatheter septal occluder (atrial). It is a Class III device, reviewed by the Cardiovascular panel.
What device class is OZG?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code OZG
- Run a recall and safety report across every OZG manufacturer
- Watch product code OZG 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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