K191935 is an FDA 510(k) clearance for the Nautilus Smart ECMO Module. This device is classified as a Oxygenator, Long Term Support Greater Than 6 Hours (Class II - Special Controls, product code BYS).
Submitted by Mc3 Incorporated (Dexter, US). The FDA issued a Cleared decision on April 9, 2020, 265 days after receiving the submission on July 19, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4100.
| 510(k) Number | K191935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 19, 2019 |
| Decision Date | April 09, 2020 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| 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 |