The following data is part of a premarket notification filed by Medtronic with the FDA for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System.
| Device ID | K203111 |
| 510k Number | K203111 |
| Device Name: | Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Medtronic 7611 Northland Drive Minneapolis, MN 55428 |
| Contact | Kaitlin Cady |
| Correspondent | Kaitlin Cady Medtronic 7611 Northland Drive Minneapolis, MN 55428 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-15 |
| Decision Date | 2021-09-16 |