BYS — Oxygenator, Long Term Support Greater Than 6 Hours Class II
FDA Device Classification
Classification Details
- Product Code
- BYS
- Device Class
- Class II
- Regulation Number
- 870.4100
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K232767 | mc3 | Nautilus VF ECMO Oxygenator | October 4, 2023 |
| K191935 | mc3 incorporated | Nautilus Smart ECMO Module | April 9, 2020 |
| K770720 | william harvey life products | TUBING PACK, EXTRACORPOREAL, H-3000 | August 4, 1977 |