510(k) K203111 ยท DTZ Oxygenator, Cardiopulmonary Bypass
Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
| Applicant | Medtronic, Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 16, 2021 |
| Received | Oct 15, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203111
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
| Jan 27, 2023 | Medtronic Perfusion Systems Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
| Jan 27, 2023 | Medtronic Perfusion Systems Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.