Panels › Cardiovascular › Product code BYS · Class 2
Oxygenator, Long Term Support Greater Than 6 Hours
Regulation 870.4100
0510(k)s in 12 months (3 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in BYS
| Company | 510(k)s | Recalls |
|---|---|---|
| Mc3 Incorporated | 2 | 2 |
| William Harvey Life Products Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K191935 |
| 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 | K191935 |
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