510(k) K232767
- Device
- Nautilus VF ECMO Oxygenator
- Applicant
- Mc3, Inc.
- 510(k) number
- K232767
- Product code
- BYS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-10-04
- Date received
- 2023-09-11
- Regulation
- 870.4100
- Classification name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Martha Rumford
- Address
- 2555 Bishop Cir. W Dexter MI US 48130 48130
FDA Registration Numbers#
- 3012172416
- 3030191221
- 9617601
- 3002845651
- 3011468686
- 9611665
- 2029275