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
Oxygenator, Cardiopulmonary Bypass
Medtronic Inc
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.
Pre-market Notification Details
| 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 |
Trademark Results [Affinity Pixie]
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 |
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