Medtronic, Inc. · Class II · Cleared Oct 25, 2017
| K-number | K172626 |
| Device name | Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir |
| Applicant | Medtronic, Inc. |
| Product code | DTZ |
| Device class | Class II |
| Decision date | Oct 25, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 870.4350 |
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