Product code BYS— Cardiovascular
Nautilus Smart ECMO Module
- Classification name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Device class
- Class 2
- Regulation
- 21 CFR 870.4100
- Advisory panel
- Cardiovascular
- Total cleared
- 3
- First cleared
- Most recent
Market context for product code BYS
FDA has cleared devices under product code BYS between 1977 and 2023, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2023
- 2020
- 1977
Top applicants under product code BYS
Adverse events under product code BYS
product code BYS- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code BYS
Data sourced from openFDA. This site is unofficial and independent of the FDA.