Device Listing 2050771994

Listing Summary#

Listing key
2050771994
Premarket submission
K183490
Device
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
Applicant
Medtronic, Inc.
Product code
DTZ
Decision date
2019-04-12