Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
FDA 510(k) clearance K203111 · decided 2021-09-16
Clearance details
- K-number
- K203111
- Device name
- Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
- Applicant
- Medtronic
- Decision
- Substantially Equivalent
- Date received
- 2020-10-15
- Decision date
- 2021-09-16
- Days to decision
- 336 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1023-2023) | Medtronic Perfusion Systems | 2023-01-27 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR recall (Z-1024-2023) | Medtronic Perfusion Systems | 2023-01-27 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1025-2023) | Medtronic Perfusion Systems | 2023-01-27 |
| Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom recall (Z-1026-2023) | Medtronic Perfusion Systems | 2023-01-27 |
| Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated A recall (Z-1027-2023) | Medtronic Perfusion Systems | 2023-01-27 |
| Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated A recall (Z-1028-2023) | Medtronic Perfusion Systems | 2023-01-27 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HeartWare HVAD System (P100047/S227) | Medtronic | 2025-07-09 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S230) | Medtronic | 2025-06-26 |
| HeartWare Ventricular Assist System (HVAD) (P100047/S229) | Medtronic | 2025-06-05 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S228) | Medtronic | 2025-06-04 |
| HeartWare HVAD System (P100047/S226) | Medtronic | 2025-05-05 |
| HeartWare® HVAD System (P100047/S225) | Medtronic | 2025-04-24 |
| HeartWare HVAD System (P100047/S224) | Medtronic | 2025-04-02 |
| HEARTWARE VENTRICULAR ASSIST SYSTEM (P100047/S222) | Medtronic | 2025-03-13 |