The following data is part of a premarket notification filed by Medtronic Inc with the FDA for 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), Affinit.
Device ID | K183511 |
510k Number | K183511 |
Device Name: | 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), Affinit |
Classification | Oxygenator, Cardiopulmonary Bypass |
Applicant | Medtronic Inc 7611 Northland Dr Minneapolis, MN 55428 |
Contact | Tyler Senjem |
Correspondent | Tyler Senjem Medtronic Inc 7611 Northland Dr Minneapolis, MN 55428 |
Product Code | DTZ |
CFR Regulation Number | 870.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-18 |
Decision Date | 2019-03-18 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AFFINITY PIXIE 77688089 4261650 Live/Registered |
Medtronic, Inc. 2009-03-11 |
AFFINITY PIXIE 77545635 4105861 Live/Registered |
Medtronic, Inc. 2008-08-13 |