FDA product code ODT: Tissue Adhesive, Aortic Aneurysmorrhaphy
ODT is the FDA product code for tissue adhesive, aortic aneurysmorrhaphy. It is a HDE device, reviewed by the Cardiovascular panel. Devices under ODT reach the market by Unclassified; FDA lists no cleared 510(k)s for it.
Definition
For use as an adjunct in the surgical repair of thoracic aortic aneurysms.
Classification
| Field | Value |
|---|---|
| Device name | Tissue Adhesive, Aortic Aneurysmorrhaphy |
| Device class | HDE |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Unclassified |
| Implant | Yes |
Recalls for ODT devices
openFDA lists no recalls for product code ODT.
Frequently asked questions
What is FDA product code ODT?
ODT is the FDA product code for tissue adhesive, aortic aneurysmorrhaphy. It is a HDE device, reviewed by the Cardiovascular panel.
What device class is ODT?
HDE. Typical premarket route: Unclassified.
Next steps
- Run an FDA pathway report with predicate devices for product code ODT
- Run a recall and safety report across every ODT manufacturer
- Watch product code ODT 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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