Medtronic, Inc. · Class II · Cleared Apr 12, 2019
| K-number | K183490 |
| Device name | Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface |
| Applicant | Medtronic, Inc. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Apr 12, 2019 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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