BYS
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Oxygenator, Long Term Support Greater Than 6 Hours
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4100
- Medical specialty
- Cardiovascular
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2005: 3 · 2007: 9 · 2023: 20 · 2024: 42 · 2025: 60 · 2026: 33
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Nautilus VF ECMO Oxygenator (K232767) | Mc3, Inc. | 2023-10-04 |
| Nautilus Smart ECMO Module (K191935) | Mc3 Incorporated | 2020-04-09 |
| TUBING PACK, EXTRACORPOREAL, H-3000 (K770720) | William Harvey Life Products Corp. | 1977-08-04 |
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Every clearance here is in the API, with alerts when new ones post.