Device Listing 1212118732
Listing Summary#
- Listing key
- 1212118732
- Premarket submission
- K183511
- Device
- 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
- Decision date
- 2019-03-18