OBI
- Product code
- OBI
- Device name
- Catheter, Pressure Monitoring, Cardiac
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (all years, FDA)
- 1 (all years; only the last 3 years are listed here)
FDA classification definition
To measure pressure within the cardiovascular system.
Official FDA classification page: OBI
Classification and pathway per current FDA publications. Data from openFDA (CC0).