DXO
- Product code
- DXO
- Device name
- Transducer, Pressure, Catheter Tip
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.2870
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 64 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251367 | 2026-01-16 | Opsens, Inc. | OptoMonitor 3 | |
| K241418 | 2025-02-12 | Opsens, Inc. | OptoMonitor 3 | |
| K233904 | 2024-07-17 | Acist Medical Systems, Inc. | ACIST RXi System (016616); ACIST Navvus II Catheter … | FDA |
Official FDA classification page: DXO
Classification and pathway per current FDA publications. Data from openFDA (CC0).