DTN
- Product code
- DTN
- Device name
- Reservoir, Blood, Cardiopulmonary Bypass
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4400
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 3
- Summaries archived here
- 3 (direct download)
- 510(k) clearances (all years, FDA)
- 169 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (3)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251783 | 2025-12-22 | Sorin Group Italia S.R.L. | Inspire HCR and HCR DUAL cardiotomy reservoirs | |
| K241206 | 2024-07-18 | Spectrum Medical S.R.L. | Quantum Perfusion Hybrid System | |
| K241053 | 2024-05-15 | Medtronic Cardiac Surgery | MVR Venous Reservoir Bag 800 mL; MVR Venous Reserv… |
Official FDA classification page: DTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).