DeviceClearance

K183511

Substantially Equivalent

Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241)

Applicant
Medtronic, Inc.
Product code
DTZ
Advisory panel
Cardiovascular
Date received
Decision date
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, 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.