Medtronic, Inc. · Class II · Cleared Mar 18, 2019
| K-number | K183511 |
| Device name | Affinity Pixie Oxygenator with Balance Biosurface (Model BBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface (Model BBP241), Affinity Pixie Oxygenator with Cortiva BioActive Surface (Model CBP211), Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Cortiva BioActive Surface (Model CBP241) |
| Applicant | Medtronic, Inc. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Mar 18, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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