Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface— 510(k) K183490
Substantially EquivalentMedtronic, Inc.
FDA 510(k) clearance K183490 for Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface, Substantially Equivalent on 2019-04-12. Applicant: Medtronic, Inc..
Clearance details
- Applicant
- Medtronic, Inc.
- Product code
- Code DTZ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Adverse events under product code DTZ
product code DTZ- Death
- 182
- Injury
- 422
- Malfunction
- 3,636
- Total
- 4,240
Source: openFDA MAUDE database, through . 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.