Medtronic Perfusion Systems · Class II · Cleared Jul 10, 2024
| K-number | K240666 |
| Device name | Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS) |
| Applicant | Medtronic Perfusion Systems |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Jul 10, 2024 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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