Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System— 510(k) K203111

Substantially Equivalent

Medtronic

FDA 510(k) clearance K203111 for Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System, Substantially Equivalent on 2021-09-16. Applicant: Medtronic.

Clearance details

Applicant: Medtronic
Product code: Code DTZ
Advisory panel: Cardiovascular
Date received: 2020-10-15
Decision date: 2021-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTZ

product code DTZ

Death: 182
Injury: 422
Malfunction: 3,636
Total: 4,240

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.