Product code
OZT: Balloon aortic valvuloplasty
FDA product code · Class II · Cardiovascular
Key facts
| Product code | OZT |
|---|---|
| Device | Balloon aortic valvuloplasty |
| Device class | Class II |
| Regulation number | 870.1255 |
| Review panel | Cardiovascular |
| Medical specialty | Cardiovascular |
| Submission type | 510(k) |
| GMP exempt | No |
| Implanted device | No |
| Life-sustaining or life-supporting | No |
| Definition | A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve. |
At a glance
- 10–99 510(k) clearances
- 1–9 De Novo grants
- None PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 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