K232767 is an FDA 510(k) clearance for the Nautilus VF ECMO Oxygenator. This device is classified as a Oxygenator, Long Term Support Greater Than 6 Hours (Class II - Special Controls, product code BYS).
Submitted by Mc3, Inc. (Dexter, US). The FDA issued a Cleared decision on October 4, 2023, 23 days after receiving the submission on September 11, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100.
| 510(k) Number | K232767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 11, 2023 |
| Decision Date | October 04, 2023 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | BYS - Oxygenator, Long Term Support Greater Than 6 Hours |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4100 |