K232767
- 510(k) number
- K232767
- Device name
- Nautilus VF ECMO Oxygenator
- Applicant
- Mc3, Inc. MI · US
- Product code
- BYS — Oxygenator, Long Term Support Greater Than 6 Hours
- Decision date
- 2023-10-04
- Date received
- 2023-09-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K232767.pdf
Official FDA record: K232767
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.