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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 4, 2023 | K232767 | Nautilus VF ECMO Oxygenator Mc3, Inc. | BYS |
| Apr 9, 2020 | K191935 | Nautilus Smart ECMO Module Mc3 Incorporated | BYS |
| Aug 4, 1977 | K770720 | TUBING PACK, EXTRACORPOREAL, H-3000 William Harvey Life Products Corp. | BYS |
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