510(k) K191935 ยท BYS Oxygenator, Long Term Support Greater Than 6 Hours
Nautilus Smart ECMO Module
| Applicant | Mc3 Incorporated, Dexter MI, US |
| Decision | Substantially Equivalent, Apr 9, 2020 |
| Received | Jul 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191935
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 19, 2024 | Mc3 Inc NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.
Product Number: (1) 48145; Open, Classified |
BYS | None listed |
| Mar 19, 2024 | Mc3 Inc NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature.
Product Number: 48135, 48 Open, Classified |
BYS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.