BYS
- Product code
- BYS
- Device name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 3
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232767 | 2023-10-04 | Mc3, Inc. | Nautilus VF ECMO Oxygenator |
Official FDA classification page: BYS
Classification and pathway per current FDA publications. Data from openFDA (CC0).