Product code
ODT: Tissue adhesive, aortic aneurysmorrhaphy
FDA product code · HDE · Cardiovascular
Key facts
| Product code | ODT |
|---|---|
| Device | Tissue adhesive, aortic aneurysmorrhaphy |
| Device class | HDE |
| Review panel | Cardiovascular |
| Submission type | HDE - Humanitarian Device Exemption |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | No |
| Definition | For use as an adjunct in the surgical repair of thoracic aortic aneurysms. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- None UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database